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Archive for the ‘Legal Issues Stem Cells’ Category

Restoring vision to the blind – Science Magazine

Friday, May 22nd, 2020

Surveys consistently report that people fear total blindness more than any other disability, and currently the major cause of untreatable blindness is retinal disease. The retina, a part of the brain that extends into the eye during development, initiates vision by first detecting light with the rod and cone photoreceptors. Four classes of retinal neurons then begin the analysis of visual images. Defects in the optical media that transmit and focus light rays onto the retina (lens and cornea) can usually be dealt with surgically, although such treatments are not available in some parts of the world, resulting in as many as 20 to 30 million legally blind individuals worldwide. Untreatable retinal disease potentially causes legal or total blindness in more than 11 million people in the United States alone, but progress in treatments raises the possibility of restoring vision in several types of retinal blindness (1).

Retinal neurons comprise bipolar and horizontal cells, which are second-order neurons that receive signals from the photoreceptors in the outer retina. Third-order amacrine and retinal ganglion cells are activated in the inner retina by bipolar cells. Axons from the ganglion cells form the optic nerve and carry the visual message to the rest of the brain (see the figure). The cells most susceptible to blinding retinal disease are the photoreceptors and ganglion cells. Whereas progress has been made in combating blindness caused by photoreceptor degeneration, little can be done currently to address ganglion cell loss, such as occurs in glaucoma.

The approach that has been most successful in restoring photoreceptor loss that results in complete blindness is the use of retinal prosthetic devices, with two now approved for clinical use (2). These devices electrically stimulate either bipolar or ganglion cells. They require goggles that have a camera that converts visual stimuli into electrical stimuli that activate the device, which in turn stimulates the retinal cells. Several hundred of these devices have been implanted in blind or virtually blind individuals, 70 to 80% of whom report improvement in quality of life. For those who are completely blind, the ability to experience again at least some visual function is viewed as a miracle.

There are substantial limitations to the devices, however. The best visual acuity attained so far is poor (20/500) and visual field size is limited, but many improvements, mainly technical, are being developed and tested, including the potential use of electronic low-vision devices to increase visual field size and acuity (3). Retinal prostheses are not useful for patients who are blind because of loss of ganglion cells and/or the optic nerve, but prostheses that bypass the retina and stimulate more central visual structures, including the lateral geniculate nucleus (the intermediary between retina and cortex) and visual cortex, are being developed and tested in humans (4). There remain considerable technical issues, but preliminary data indicate that such devices are feasible.

A second approach to treat photoreceptor degeneration and potential blindness, now in the clinic, is gene therapy (5). This involves injecting a viral construct into the eye that contains a normal gene to replace an abnormal one. Success so far has been limited to the treatment of Leber congenital amaurosis (LCA) type 2, a rare form of retinitis pigmentosa in which the gene whose product is required to form the correct isomer of vitamin A aldehyde, the chromophore of the visual pigments, is mutated. Little of the correct isomer is made in LCA patients, resulting in substantial loss of photoreceptor light sensitivity. This is reversed when viral constructs encoding the normal gene are injected deep into the eye between the photoreceptors and pigment epithelium.

Two factors make this approach feasible in LCA: The genetic defect is monogenic, and many of the photoreceptors in the patients remain alive, although compromised. Thus, how broadly feasible gene therapy will be for treating the enormous range of inherited retinal diseases now known to exist (300) remains to be seen. But at least a dozen other gene therapy trials on monogenic inherited eye diseases similar to LCA are under way (6). Other methods to manipulate genes are now available, including CRISPR-mediated editing of retinal genes. So far, the experiments have been mainly on isolated cells or retinas, but these powerful techniques are likely to have eventual clinical applications.

A variation on the use of gene therapy techniques is optogenetics, in which light-sensitive molecules are introduced into non-photosensitive retinal cells. This approach holds much promise for restoring vision to totally blind individuals whose photoreceptors have been lost. Using viruses to insert genes encoding light-sensitive molecules into bipolar and ganglion cells, as well as surviving photoreceptor cells that are no longer photosensitive, has been accomplished in animals and shown to restore some vision (7). Again, technical issues remain: The cells made light-sensitive require bright light stimuli, and the light-sensitive cells do not adapt. That is, whereas photoreceptors normally allow vision over as much as 10 log units of light intensity, the cells made light-sensitive respond only to a range of 2 to 3 log units. Various methods to overcome these limitations are now being developed, and at least one clinical trial is under way. Experiments to make cortical neurons sensitive to light or other stimuli that better penetrate the skullmagnetic fields or ultrasound, for exampleare also being developed and tested in animals.

Other promising approaches to restore vision are being explored. In cold-blooded vertebrates, retinal cells (in fish) and even the entire retina (in amphibians) can regenerate endogenously after damage. Regeneration of retinal cells in zebrafish is now quite well understood (8). The regenerated neurons come from the major glial cell in the retina, the Mller cell. After retinal damage, Mller cells reenter the cell cycle and divide asymmetrically to self-renew and produce a progenitor cell that proliferates to produce a pool of cells capable of differentiating into new retinal cells that repair the retina.

A number of transcription factors and other factors identified as being involved in retinal regeneration in zebrafish have been shown to stimulate some Mller cell proliferation and neuronal regeneration in mice. Regenerated bipolar and amacrine cells, as well as rod photoreceptors, have so far been identified in mouse retinas, and these cells are responsive to light stimuli (9, 10). Further, cells postsynaptic to the regenerated neurons are activated by light stimuli, indicating that the regenerated neurons have been incorporated into the retinal neural circuitry. So far, the regenerative capacity of mammalian Mller cells is limited, but directed differentiation of specific types of neurons with a mix of factors appears to be a possibility. Regrowth of ganglion cell axons after the optic nerve is disrupted is also under active investigation, and although the number of axons regrowing is low (10%), those that do regrow establish synaptic connections with their correct targets (11). Therefore, endogenous regeneration is still far from clinical testing, but substantial progress has occurred.

The retina lines the back of the eye and consists of rod and cone photoreceptors, as well as four types of neuron: second-order bipolar and horizontal cells and third-order retinal ganglion cells (RGCs) and amacrine cells. Mller glial cells fill the spaces between the neurons. The pigment epithelium, critical for photoreceptor function, underlies the retina. Photoreceptors and RGCs are most susceptible to blinding retinal disease. Progress in combating photoreceptor degeneration has been made, but there are few strategies to address RGC loss.

A long-studied area of research is transplantation of retinal cells, particularly photoreceptors, into diseased retinas. In experiments with mice, transplanted postmitotic rod photoreceptor precursor cells derived from embryonic retinas or from stem cells appeared to integrate into diseased retinas in reasonable numbers and to be functional. A surprising and unexpected complication in the interpretation of these experiments was recently discovered. Rather than integrating into diseased retinas, the donor cells appear to pass material (RNA or protein) into remaining host photoreceptor cells, rejuvenating them, and these appear to be most of the functional cells (12). The current evidence suggests that only a small proportion of the donor cells integrate, but progress in overcoming this setback is being made.

More success has been reported with stem cells induced to become pigment epithelial (PE) cells, which provide essential support for photoreceptors. A number of blinding retinal diseases relate to the degeneration of the PE cells, and replacement using such cellsin a suspension or on a scaffoldis being actively pursued. PE cells do not need to integrate synaptically with retinal cells; they simply need to contact the photoreceptor cells. This is achieved when PE cells are placed between the retina and the back of the eye. Early clinical trials suggest that the transplants are safe, but retinal detachment, a serious complication, can occur and efficacy has yet to be shown (13).

The finding that donor photoreceptor cells can help diseased host retinal cells to recover function suggests that certain substances can provide neuroprotection. Indeed, a substantial number of such neuroprotective molecules have been shown to affect retinal disease progression, especially degeneration of photoreceptor cells. No one factor has been shown to be effective generally, but two have received much attention. One, ciliary neurotrophic factor (CNTF), promotes photoreceptor survival in light-induced photoreceptor degeneration and in several other models of retinal degeneration (14). Some evidence suggests that CNTF acts primarily on Mller cells, but how it works, and on what cells, is still unclear. The other factor, rod-derived cone viability (RDCV) factor, has received less research attention, but with recent industrial support, it is now being advanced to the clinic. Current evidence indicates that RCDV factor protects cones after rod degeneration.

Two of the most common retinal diseases in developed countriesage-related macular degeneration (AMD), the leading cause of legal blindness (visual acuity of less than 20/200), and glaucoma, the leading cause of total blindnessare not monogenic diseases, and so genetic treatments for them are not obvious. Attempts to understand the etiology of these diseases are under way, but currently their underlying causes are still unclear. A difficulty presented by AMD is that no animal model is readily available, because it is a disease of the fovea, which mediates high-acuity vision. Except for primates, other mammals do not possess this small critical retinal area. Whereas large primates are not feasible for extensive cellular or molecular studies, small primates such as marmosets that have a fovea are potential models but have not been used much to date.

Other approaches for restoring vision have been suggested and have even yielded some progress. From both normal humans and those with an inherited retinal disease, skin biopsy cells can be induced to form tiny retinal eyecups called organoids (15). Containing all retinal cell types, these structures could be a source of retinal cells for studying retinal disease development and possible therapies, as well as for cell transplantation. A fovea has not been observed in any organoid so far, but this is not beyond the realm of possibility. Another suggested approach is to surgically transplant whole eyes into blind individuals. This appears feasible, but whether there is sufficient optic nerve regrowth remains an open question.

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Restoring vision to the blind - Science Magazine

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Death of a Survivor – The New Republic

Monday, May 4th, 2020

Having served over half her sentence, Lulu was a candidate for medical parole based on her age and health even before the coronavirus crisis. Her medical history included chronic obstructive pulmonary disease, hepatitis C, seizure disorder, and stage stage-five chronic kidney disease. She also had a heart attack and open-heart surgery in January. Release for Lulu and others in similar situations became a more urgent public health issue during the pandemic. Since early March, academic experts, medical and legal professionals, and advocates have been requesting broad release for incarcerated New Yorkersespecially the elderly, the pregnant, and those with underlying health conditions.

In jails and prisons, social distancing is impossible, and there are minimal sanitary supplies and limited medical capacity. The Release Aging People from Prison (RAPP) Campaign had called for the 9,550 people age 50 and older in state prisons be freed. As of April 30, Cuomo had released 116 older people from prisonor approximately 1 percent of the over-50 population. (He also ordered the release of up to 1,100 people in local jails on low-level parole violations.) Were Cuomo to allow the most vulnerable to go home, Donna Robinson, RAPPs Western New York regional organizer, told me, so many lives would not be lostnot only of people who are incarcerated, but the guards, the vendors, the volunteers.

As of May 1, 1,074 staff members and 375 incarcerated people at New York State prisons are confirmed positive for Covid-19; ten incarcerated people and two staff members have died. On March 30, a top doctor at New Yorks Rikers Island Jail tweeted that, in 12 days, one Covid-19 case had exploded into 200, that the virus was spreading rapidly, and that it was unlikely that the jail could stem the growth. By April 30, there were 376 cases, an infection rate of nearly 10 percent, compared to the civilian rate of 1.5 percent in the rest of the state. All numbers only reflect those who have been given tests, which are notoriously in short supply. When the Bureau of Prisons, which controls federal facilities, tested 2,700 incarcerated people for Covid-19, 71 percent of the tests came back positive.

All visitation to Bedford Hills was canceled on March 16. Incarcerated women, civilian workers, guards, and their families fell ill. Lulu wrote to Melissa on March 20, cheerful as usual, grateful for her care package of popcorn and Honey Buns. Hey Sis, How are you doing? Is the sun out up north? I got the stuff you sent me Thank you very much for all that you did Love you both and tell the kids I said hello and to continuously wash their hands and face. Love LuLu. As the virus circulated, she grew anxious. On March 28, she asked Melissa to contact people in higher places and let them know. With her underlying health issues, she added, I cannot afford to get this virus. It may kill me. Please help.

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Death of a Survivor - The New Republic

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Could Cannabis Be an Effective Treatment for COVID-19? – Lab Manager Magazine

Wednesday, April 29th, 2020

With COVID-19 continuing to spread all over the world, researchers are looking into numerous options for possible treatment, including existing drugs. Medical cannabis is one option thats gained a lot of attention, but while early research shows some promise, its much too early to be considered a safe and effective treatment.

Likely due to the continued restrictions on cannabis research in the US, there are not yet any studies in the country focusing on cannabis as a possible treatment or prevention for COVID-19. However, earlier this month, University of Miami researchers launched a study into how the novel coronavirus is impacting American cannabis users during the peak of the outbreak.

The global qualifying conditions for medical cannabis, though not uniform, all include individuals with compromised immune systems and other chronic health conditions. Therefore, this is a population that we cannot forget about in our joint effort to flatten the curve,'" Denise C. Vidot, an assistant professor in the School of Nursing and Health Studies and a trained epidemiologist, said in a press release.

More recently, a partnership between cannabis research companies Pathway RX and Swysh Inc. and the University of Lethbridge in Alberta, Canada, found that certain Cannabis sativa extracts could be used in treatments to prevent infection with SARS-CoV-2, the virus that causes COVID-19.

Specifically, they found that the extracts have an effect on the expression of ACE2 and TMPRSS2, proteins in human cells that research has shown to be an entry point for the virus. However, their research has only just been submitted for publication and has not yet been peer reviewed.

While our most effective extracts require further large-scale validation, our study is crucial for the future analysis of the effects of medical cannabis on COVID-19, the researchers said in an early pre-publication version of their study. The extracts of our most successful and novel high CBD [cannabidiol] C. sativa lines, pending further investigation, may become a useful and safe addition to the treatment of COVID-19 as an adjunct therapy.

They add that their extracts could potentially be used in a mouthwash or throat gargle to prevent COVID-19 coronavirus infection.

Similar research was recently launched in Israel. InnoCan Pharma Ltd, an Israeli pharmaceutical company focused on cannabis therapies, announced Apr. 17 that it is partnering with Tel Aviv University to develop a possible cell therapy treatment that uses CBD-loaded exosomes to treat those with COVID-19. The product, which the company says will likely be given to patients through inhalation, will also be tested as a treatment for other lung infections.

Exosomes are small particles created when stem cells are multiplied, InnoCan said in a recent statement. Exosomes can act as homing missiles, targeting specific damaged organs and have an important role in cell-to-cell communication. When the cell healing properties of the exosomes are combined with the anti-inflammatory properties of CBD, it is expected to reach high synergetic effect.

Also in Israel, the Medical Cannabis Network reports that researchers at the Israel Institute of Technology and their partners are working on two studies exploring the use of a cannabis terpene formulation, also administered by inhalation, in the treatment of COVID-19. The first study will focus on the effect of Cannabis molecules on the immune system, while the second study will investigate the ACE2 receptor and how the terpene treatment could prevent viral entry to human cells through this pathway.

Another Israeli cannabis research company, Stero Biotechs, was also to launch a small clinical trial this month studying the effectiveness of a CBD-steroid treatment in 10 COVID-19 patients at Rabin Medical Center, according to an Apr. 19 press release.

This isnt the first time cannabis has been investigated as a prevention and treatment strategy for a coronavirus. Earlier research has looked at the drugs effect on SARS-CoV, the coronavirus that causes Severe Acute Respiratory Syndrome, which caused an outbreak in 2003. In a 2007 study, researchers from China examined the antiviral properties of cannabis against SARS-CoV.

They looked at 221 phytocompounds, finding that specific abietane-type diterpenoids and lignoids exhibit strong anti-SARS-CoV effects.

However, those thinking of upping their cannabis intake in the hopes of preventing or treating COVID-19 infection should take these early results with a large grain of salt. In particular, smoking more cannabis is likely to put people at greater risk of infection, health authorities stress.

The research community should be alert to the possibility that [COVID-19] could hit some populations with substance use disorders particularly hard, the US National Institute on Drug Abuse says in a statement. Because it attacks the lungs, the coronavirus that causes COVID-19 could be an especially serious threat to those who smoke tobacco or marijuana or who vape.

As for those wondering if edibles or oils are a safer solution, there just isnt enough research to prove these products are truly effective against COVID-19 either.

With current research on cannabis as a COVID-19 prevention and treatment strategy still in the very early stages, it will likely be some time before we have a clear answer as to whether these products are safe and effective options. The studies in Israel have only just been launched with no solid timeline on when the results will be out, and the Canadian researchers are still looking for partners to run clinical trials with their cannabis extracts.

While it will likely be frustrating for those who want a clear answer now, it will be many months before we know for sure whether cannabis is a safe and effective option against COVID-19.

Editors note: So far, there is no approved treatment or vaccine for COVID-19. This article is meant to be a summary of some of the research so far into cannabis as a possible COVID-19 treatment, not an endorsement of its use as such. With the COVID-19 situation rapidly changing, always consult your local health authority and health care provider for the most up-to-date information on treatment options and cannabis use during the pandemic.

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Could Cannabis Be an Effective Treatment for COVID-19? - Lab Manager Magazine

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The Republicans who were once so pro-life they fought over one woman on life support now want to sacrifice grandma for the economy – The Independent

Wednesday, April 29th, 2020

Years after the United States elected a president with the motto America First, we just pulled ahead in a race no one wants to win: the most deaths from the novel coronavirus. In order to limit casualties from a catastrophic second wave, states have enacted measures of differing severity, from shutting down some businesses to move severe shelter in place orders mandating citizens stay in their homes.

However, months into this disruption, some restless Americans are looking for a way out and there are Republican politicians eager to placate them. Senator Rand Paul of Kentucky bemoaned the lack of commerce on Twitter and threw his support behind re-opening the economy. Georgia Governor Brian Kemp is way ahead of him, announcing plans to lift restrictions on businesses from bowling alleys to hair salons amidst widespread pushback in his own state. Lt. Governor Dan Patrick of Texas skipped the subtext and went straight to the point with the breathtaking assertion that there are more important things than living, a statement that presumably doesnt include himself or his loved ones.

Its puzzling how these politicians think re-opening will lead to business as usual with an unpredictable contagion floating around. Commerce relies on consumers, and if a majority of those consumers are rightfully afraid for themselves and their families, how exactly is the government supposed to put things back to pre-pandemic levels without forcing us to go to the mall on pain of arrest?

Sharing the full story, not just the headlines

Even if they just intend to let those who dont care about the risks shop, go to work and pretend everything is normal, theres a very real danger that way more Americans will die as a result. But according to Lt. Gov. Patrick, its a justifiable sacrifice for the good of the nations GDP.

This is fascinating coming from a party that has long labeled itself as pro-life over the years when it suits them. Lets look at one of the most extreme examples: Terri Schiavo, a woman whose private medical battle became a tool for the Republican party during the early 2000s. After a Florida trial court concluded that Schiavo was in a persistent vegetative state and would have wanted the feeding tube keeping her alive to be removed, Republicans at all levels became involved. Governor Jeb Bush pulled in everyone from his brother in the White House to the United States Congress to unsuccessfully fight the trial courts order for years. It would seem to a casual observer that this was a political party that would stop at nothing to save a life.

This wasnt the first time Republicans (or the Bushes) were performatively pro-life. During his first year in office President George W. Bush severely limited federal funding for research involving embryonic stem cells, giving evangelical conservatives an important win. Bush continued to oppose bills to loosen these restrictions, citing concerns that taxpayers would be funding the destruction of potential life. Again, if you didnt know anything else about the GOP you would think that their concerns were so pure as to encompass cells that could become a human being someday.

This stated concern for life didnt stop with the Bush brothers. Republicans took a stand during debates surrounding President Obamas signature legislation, the Affordable Care Act. This proposed legislation aimed to increase the amount of people with health insurance (which is positively correlated with life preservation). However, former GOP vice presidential candidate Sarah Palin asserted repeatedly that the law would lead to death panels that would decide whether elderly Americans would live or die. Inspired by Palin, the right painted a dystopian picture of a future where liberal judges would decide grandmas fate. A decade later and pearl-clutching at treatment of older Americans has taken a turn since they are inconveniently deemed to be more at risk of dying of Covid-19. Now the elderly, it seems, are at best inessential to public life and, at worst, expendable sacrifices to the gods of capitalism.

Here is whats revealing in each of those episodes: championing the life of Terri Schiavo, or the potential life of stem cells, or the imaginary life of a condemned grandma didnt cost Republicans a nickel. But the people who would potentially die if re-opening measures are scaled back are expensive. Theyre also inconvenient for the partys narratives. They include the medical workers who counter-protest the Confederate flag-wavers who want to be able to get a haircut. They are immigrants who risk their lives to provide you with food. They are, disproportionately, black, indicative of the virulent racism in our country.

Championing their lives means economic sacrifice with no legislative gain. That is, apparently, a bridge too far.

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The Republicans who were once so pro-life they fought over one woman on life support now want to sacrifice grandma for the economy - The Independent

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Russia’s Humanitarian Law Obligations to Civilians in Occupied Ukrainian Territories in the Time of COVID-19 – Just Security

Wednesday, April 29th, 2020

(Editors note: This is the first of a two-part analysis by Global Rights Compliance of the application of international humanitarian law (IHL) in areas under occupation during the coronavirus pandemic, with the Russian occupation of parts of Ukraine as a case in point. Part 1 discusses Russias obligations and compliance in protection of civilians from the effects of the virus. Part 2 will consider to what extent Ukraine, as the displaced sovereign, retains residual obligations to provide further protection.)

As the coronavirus works its way across the globe, compliance with international humanitarian law (IHL) standards is paramount for the protection of survivors of armed conflict. The pandemic particularly highlights the vulnerability and conversely, the legal rights of populations living under occupation, whose lives depend on the willingness of the occupying State to abide by the letter and spirit of IHL.

The Russian Federations occupation of parts of Ukraine is a useful example. Ukraine is one of 10 States and territories currently under foreign occupation in the world. The others are: Azerbaijan, Cyprus, Eritrea, Georgia, Lebanon, Moldova, Palestine, Syria and Western Sahara. (see here, p. 32). Occupying powers in these territories are bound by a range of specific obligations under IHL related to providing health care for the populations living under their control. Non-compliance with these obligations can have harmful, if not catastrophic, consequences for these populations, especially in the midst of a crisis as deadly as the coronavirus pandemic. This is especially so in the frequent scenario wherein the occupier disputes its status as an occupying power and therefore, refuses to assume its IHL obligations.

The following discussion is premised on the clearest of legal indications that the Russian Federation is an occupying power in Crimea and bound by a panoply of IHL obligations that require a robust response to any public health crisis to ensure that the civilian populations medical and health requirements are met. There is international consensus on the occupied status of Crimea (see here, here and here). The Russian Federation has been an occupying power in Crimea and, arguably, eastern Ukraine since 2014 (for more information, see here and here). Whilst the Kremlin disputes this status, they are alone in this view.

The situation in eastern Ukraine and the question of Russias IHL status is more complicated. Since 2014, two non-State armed groups (NSAGs) the Donetsk Peoples Republic (DPR) and the Luhansk Peoples Republic (LPR) have exercised territorial control over parts of eastern Ukraine. For the purposes of this analysis, the question may be viewed as one of control, namely who is in actual control: the Russian Federation or these NSAGs (which themselves, are unquestionably supported by Russia) that purport to independently administer the territory?

If the Russian Federation exercises overall control over these NSAGs, it follows that it is to be legally deemed an occupying power (see, Blaki Trial Judgment, para. 149) and is therefore obligated to fulfil all IHL obligations applicable to an international armed conflict (IAC) (as outlined below). In the event that the facts do not meet this threshold, the DPR and LPR, as NSAGs exercising control over parts of eastern Ukraine, will themselves be required to meet a range of less demanding and detailed (but, nonetheless, still considerable) IHL obligations applicable to non-international armed conflicts (NIACs).

The Overall Control Test

Legally speaking, the overall control test dictates when a State is deemed responsible for the actions of a NSAG, or other non-state actor. Overall control exists where the State in question has a role in organising, coordinating or planning the military actions of the military group, in addition to financing, training and equipping or providing operational support (see the Tadi Appeal Judgment, para. 137, and GRCs note on the subject). In the words of the late international law luminary Antonio Cassese, the State in question must have a say in and an impact on, the planning and organisation of the groups activities (see here, p. 661). The extent of this impact must go beyond mere coordination and cooperation between allies (see Tadi, para. 152). Whether overall control exists is a factual determination, made on a case-by-case basis.

Differing from the International Court of Justices effective control test, the overall control test does not require a demonstration that the State in question planned or directed all of the relevant groups actions, issued specific orders and instructions on the conduct of military operations or chose the groups targets (Tadi, para. 137). Instead, the existence of overall control may be inferred in the following circumstances: (i) the State generally directs, coordinates or helps the armed group in its actions, including by participating in the planning and supervision of its military operations, (ii) the State exercises control over the political and military objectives of the group, and (iii) the group is (financially or otherwise) dependent on the State (Tadi, paras. 138, 145, 150-154; and Cyprus v. Turkey, in the European Court of Human Rights, para. 77).

Regrettably, in-depth analysis of this threshold has been lacking both in and out of Ukraine. Nevertheless, there are strong indications that the Russian Federation is in overall control of the DPR and LPR. First, despite repeated denials by Russian officials, there is mounting evidence of direct Russian military involvement in the conflict in support of the DPR/LPR. To this day, despite purporting to play a neutral role in the ceasefire and peace talks in eastern Ukraine, it appears that the Russian Federation has not only trained, armed and equipped the DPR/LPR forces, but also coordinated with them in the planning and execution of military operations against the Ukrainian armed forces (see here and here). This includes the direct participation of Russian troops in hostilities in support of DPR/LPR forces (including by cross-border shelling from Russian territory), as well as the provision of military training and the transfer of large quantities of advanced weaponry, including defense systems, artillery, tanks and armored personnel carriers, to these groups (see the International Criminal Court Prosecutors 2017 Preliminary Examination Report on the situation in Ukraine at para. 92; see also here, here, here, here, here, here and here). By March 2, 2015, the U.S. Army Europe Command estimated that 12,000 Russian soldiers including military advisers, weapons operators and combat troops were active in eastern Ukraine.

Still, the question remains whether this far-reaching assistance indicates a relationship of cooperation/coordination between allies or of overall control. Recent developments in litigation concerning the downing of flight MH17 in Dutch courts provide further insights into the likely role of the Russian state. Three of the individuals indicted in the case, due to the leading role they played in the commission of the crime (Igor Girkin, Sergey Dubinsky and Oleg Pulatov), are Russian nationals and former members of the GRU and FSB, the two main Russian intelligence agencies. At the time of the incident, these individuals also held high-level positions in the DPR (Girkin was the Minister of Defense; Dubinsky was Girkins deputy and the head of the DPRs intelligence service; and Pulatov was Dubinskys deputy). These facts suggest that the role played by the Russian Federation in the DPRs military operations goes far beyond mere coordination or provision of training and arms. Rather, it seems that, through its operatives, the Russian Federation has directly participated in the organization, planning and supervision of the DPRs military operations.

This is an illustrative demonstration of the Russian Federations modus operandi in exercising control over eastern Ukraine: infiltrating the higher echelons of DPR/LPR governmental structures with Russian operatives (and eliminating any dissenting elements therein), allowing Russia to exert control over the military objectives and actions of these groups, while at all times retaining a measure of plausible deniability (see here, here and here). Such control, however, is not limited to the military sphere. An email leak in October 2016 revealed how the Russian Federation also manages and controls political developments within the DPR and LPR, for instance, by vetting/reviewing prospective members of their respective governments (for a detailed analysis, see here).

Moreover, and of particular note during the time of COVID-19, is the degree of financial dependency. The Russian Federation supports the economies of these entities by spending an estimated $2 billion annually in non-military expenditures in eastern Ukraine. In 2015, the Russian Federation began paying pensions, benefits, and wages to members of both entities, leading to significant economic dependency.

In sum, the level of Russian involvement in military, political and financial spheres have led commentators to conclude that the LPR and DPR are not autonomous actors but in fact, puppets that operate under the complete and direct military and political control of the Russian Federation (see here, here and here). While this analysis is based in part on the geopolitical realm, there does appear to exist substantial legal reason to believe that Russia is in overall control of both the LPR and DPR and thus, legally qualifies as an occupying power in eastern Ukraine.

Russias IHL Obligations

IHL provides occupying powers with an overarching duty to restore and ensure public order and safety within occupied territories (Hague Regulations, Art. 43). This obligation derives from their forceful supplanting of the authority and control of the prior sovereign power and consequent disruptions to the provision of essential public services to the population. IHL requires the occupying power to assume responsibility for these services.

Provision of health care is one such service. The occupying power has the duty to ensure public health and hygiene in occupied territories and meet the medical needs of the population without any adverse distinction (See Geneva Convention IV, Arts. 27, 55 and 56; and Additional Protocol I, Art. 14). According to the International Committee of the Red Cross (ICRCs) influential commentaries to the Geneva Conventions, Article 55 of the Fourth Geneva Convention requires an occupying power to maintain at a reasonable level the material conditions under which the population of the occupied territory lives. To this end, and to the fullest extent of the means available to it, the fourth Geneva Convention stipulates in Article 56 that an occupying power must maintain hospital establishments and related services, including by promptly organizing new hospitals if necessary. Medical services must be of good quality, meaning that they are provided in facilities that satisfy certain minimum standards (such as having access to safe and potable water and adequate sanitation) and staffed by skilled medical personnel who treat patients using appropriate medications and equipment (see this influential commentary on the Geneva Conventions, p. 1498). Similar, but less detailed, obligations apply to NSAGs during NIACs (see Geneva Conventions I-IV, especially Common Article 3; Additional Protocol II, Art. 7; Rule 110 of the ICRCs study of customary IHL; and the ICRCs Commentary on the Additional Protocols, p. 1409).

Additionally, the occupying power must ensure that adequate medical supplies are available to meet the needs of the population of the occupied territory, including by procuring such supplies when necessary (Geneva Convention IV, Art. 55). If the population is inadequately supplied, the occupying power must agree on relief schemes with other States or impartial humanitarian organizations (such as the ICRC) to allow and facilitate the provision of medical aid to the population (Geneva Convention IV, Arts. 23, 59). For rules applicable to NIACs, see Additional Protocol II, Arts. 9 and 18; ICRC Rule 55).

Particularly relevant to the current crisis, an occupying power is required to adopt and apply prophylactic and preventive measures necessary to combat the spread of contagious diseases and epidemics (Geneva Convention IV, Art. 56). As noted in the authoritative ICRC commentary, measures taken to satisfy Article 56 should include:

supervision of public health, education of the general public, the distribution of medicines, the organisation of medical examinations and disinfection, the establishment of stock of necessary medical supplies, the despatch of medical teams to areas where epidemics are raging, the isolation and accommodation in hospital of people suffering from communicable diseases, and the opening of new hospitals and medical centres.

These obligations are broadly consistent with the World Health Organization (WHO) guidelines on ensuring public health and safety during the COVID-19 pandemic. In short, WHO advises States to, among other things: (i) communicate to the public the facts about the pandemic, (ii) adopt public health measures, such as social distancing and travel-related measures, (iii) identify, isolate and provide optimized care for infected patients, especially those who are particularly vulnerable, and (iv) enhance the preparedness and capacity of health care facilities (including the knowledge of the medical personnel) to meet expected surges in COVID-19 cases (see also here and here).

Russias Response to COVID-19 in Crimea and Eastern Ukraine

An examination of the Russian Federations response to the COVID-19 pandemic in Crimea and eastern Ukraine exposes a range of deficits that likely entail breaches of various IHL obligations.

As of April 21, there were 46 confirmed cases of COVID-19 in Crimea and 57 in relevant parts of eastern Ukraine (36 in DPR controlled areas and 21 in LPR controlled areas). There is, however, reason to doubt the accuracy of these figures. Firstly, in a general sense, neither the Kremlin nor its agents are known for their truthfulness and transparency in normal times, let alone during times of urgency or emergency. Ukrainian authorities claim that the DPR and LPR authorities have suppressed actual infection and mortality figures (see here and here). Doctors are purportedly being silenced, including being required to sign non-disclosure forms and to re-classify autopsy reports. Similar claims have been made by Ukrainian Ombudsman Lyudmila Denisova in relation to the spread of coronavirus in Crimea. These claims, if true, point to a deliberate attempt on the part of Russian occupation authorities to avoid their responsibilities to the populations of Crimea and eastern Ukraine by keeping them (and the international community) in the dark.

Further evidence of this neglect may be seen in the introduction of emergency measures in Crimea. Despite the preventative measures the Russian Federation took within Russia itself to curb the spread of the coronavirus as early as January, corresponding measures apparently were not put in place in Crimea until March 17. Enacted measures include prohibitions on sports, cultural, public, and other large gatherings; suspension of the activities of restaurants, cafes, education institutions, and public transportation services; isolation of individuals arriving in Crimea from other territories of the Russian Federation; and mandatory quarantine measures and travel restrictions (see here, here and here). Similar, albeit milder, measures have been put in place by the DPR and LPR authorities (see here).

The adoption of these physical distancing measures is certainly a step in the right direction. Nevertheless, as will be discussed below, the Russian occupation authorities appear grossly ill-prepared to take the further steps necessary to comply with their IHL obligations.

The Inadequacies of Health Services in Crimea and Eastern Ukraine

The Russian health-care system introduced into Crimea after the occupation is beset with major shortcomings across a range of essential services relevant to the treatment of infectious diseases. Of significant relevance to IHL obligations more broadly, and in direct contravention of the specific requirement that the provision of health care in occupied territory be made without any adverse distinction (see Geneva Convention IV, Art. 27), is that Ukrainian citizens who refuse to acquire Russian citizenship and residence permits are denied access to medical services (see here, pp. 11-12).

Similarly, Russian authorities seem to be failing to maintain the health services at a reasonable standard to meet the medical needs of the population in Crimea and eastern Ukraine. Local residents report that the conditions in Crimean medical facilities do not satisfy basic sanitary standards. For example, the mother of a teenage patient exposed the inadequate conditions in the Kerch City Hospital in the east of Crimea, which lacks access to running water, sufficient heating, and electricity. Another resident shared photos from the main Bakhchisaray and Yalta City Hospitals, revealing the unsanitary conditions there, including fungus growth on the walls and soiled bedsheets. In Sevastopol City Hospital, on the other hand, patients complain that there is only one functioning toilet for 60 people.

Moreover, according to the Crimean Human Rights Group, the number of medical personnel who know how to treat COVID-19 patients in Crimean hospitals is extremely low, meaning that proper COVID-19 testing, diagnosis, and treatment remains the exception. Rather than conducting appropriate medical examinations and isolating/treating COVID-19 patients at hospitals, medical personnel send those who show symptoms home to self-isolate. Even the relatives or other persons living in the same household with those who were diagnosed with COVID-19 are denied testing and admission to hospitals.

These shortcomings have already proven to be deadly for those most vulnerable. On March 31, a 65-year-old resident of Kerch with a high fever and heavy coughing was denied admission to a hospital by the emergency medical staff. He was admitted to the intensive care unit two days later with more severe symptoms, where he eventually died. His family was not informed of the cause of his death.

While there is not the same amount of information available in Donetsk and Luhansk, even more serious problems appear to undermine medical responses there. As outlined by the United Nations, people (especially older persons) residing in eastern Ukraine conflict zones, including numerous isolated villages, face serious limitations in accessing vital healthcare due to the distance, the cost of travel, the unavailability of medication, medical personnel, and lack of transportation such as ambulances (see here, here, para. 36 and here para. 7).

Lack of Adequate Medical Supplies

Lastly, both Crimea and eastern Ukraine seem to be under-resourced in relation to the type of medical supplies necessary to help stem the spread of, or treat those infected with, the coronavirus. Activists across six Crimean cities checked 16 pharmacies and reported there to be no face masks or hand sanitizers available, and shortages on medications. The main hospitals in Armyanks and Sevastopol City, on the other hand, lack sufficient protective equipment for both health workers and patients.

Further, throughout Crimea (with a population of more than 2 million), the medical facilities where COVID-19 patients are treated have a total of 212 ventilators available. Similarly, even these limited resources are largely unavailable in Donetsk and Luhansk. According to LPR medical professionals, local hospitals are unprepared to deal with a near-inevitable COVID-19 outbreak and lack the resources to treat any high number of patients. A report by Ukrainian authorities noted that Donetsk and Luhansk residents showing symptoms of COVID-19 are often diagnosed with general viral infections and sent home, in large part due to the lack of medical personnel, test kits, and hospital beds.

These shortcomings indicate that the Russian Federation is failing to respond to the COVID-19 pandemic in any meaningful way in line with its obligations under IHL. Russian authorities do not have to do the impossible nor achieve perfection. Rather, the Russian government must urgently utilise all the means at its disposal (i.e. the fullest extent of means available to it) to bring the health-care standards in Crimea and eastern Ukraine to a reasonable level. That includes: (i) improving the conditions and resources of the existing medical facilities, (ii) establishing new medical facilities if needed, and (iii) ensuring that the medical supplies necessary to address COVID-19 are adequate for the population (see ICRC Commentary on Geneva Convention IV, Arts. 55 and 56).

Any claim by Russia to not having the means to improve health conditions in occupied areas of Ukraine should be carefully scrutinized. Of particular concern is Russias apparent lack of effort to fulfil the WHOs recommendations that require, at a minimum, enhancement of the capacity of health facilities (including expert medical personnel) to address the elevated and specific demands corresponding to the coronavirus pandemic. Moreover, any bona fide claim along these lines would need to be evidenced by Russian efforts to reach agreements with other States or impartial organizations such as the ICRC to allow and facilitate required medical assistance to the occupied territories (see ICRC Commentary on Geneva Convention IV, Art. 59). In sum, as the 11th largest economy in the world, the Russian Federation has an uphill battle to convince the international community that it does not have the material resources to meet these obligations.

Russias IHL Obligations to Confined Persons

IHL provides specific health safeguards for persons who are deprived of their liberty in occupied territories because they are particularly vulnerable. Detained or interned persons must be: (i) kept in conditions of hygiene sufficient to ensure good health, (ii) provided with any medical attention they require, and (iii) given the right to be visited by ICRC personnel (see Geneva Convention IV, Arts. 76, 81; for NIACs see Additional Protocol II, Art 5(1)(a), (2)(d) and ICRC Rules 118).

WHO guidelines on responding to the pandemic in prisons and other places of confinement provide some insights on what these obligations may entail. According to WHO, incarcerated persons should: (i) be protected from infection by screening those who access the prison and adopting social distancing measures, (ii) be given adequate space, air exchange, and routine disinfection of their environment, (iii) receive access to adequate health care, personal hygiene facilities (e.g. hot water and soap), and protective equipment such as masks and gloves, without discrimination, (iv) be screened for COVID-19 symptoms and put in medical isolation for further medical evaluation/testing if need be, (v) be treated on-site or be transferred to specialist facilities if they have contracted COVID-19, and (vi) be allowed to receive visits from international or domestic monitoring organizations.

Detention Conditions in Crimea and Eastern Ukraine

Conditions imposed on detainees in occupied Crimea and eastern Ukraine fall significantly short of IHL requirements and WHO standards and regretfully, pave the way for a perfect storm in the event of a coronavirus outbreak in the region. Reportedly, detention facilities in Crimea lack medical staff, medications, equipment (such as masks or ventilators) as well as expertise in the treatment of COVID-19 patients. Sanitation and hygiene conditions are extremely poor. Detainees do not have adequate access to water or ventilation and live in overcrowded cells. Prisoners risk infection due to daily inspections and searches conducted by the prison staff who carry out their duties without any protective equipment. No social distancing measures are in place.

More disturbingly, those who show symptoms of COVID-19 are denied appropriate medical treatment, testing, or hospitalization, significantly increasing the likelihood of infecting other prisoners as well as staff. For instance, Server Mustafayev, a Crimean Tatar prisoner of conscience and the coordinator of the civil society organization Crimean Solidarity was denied any meaningful medical attention or hospitalization, even though he was suffering from a dry cough and breathing difficulties with a fever and temperature of 39.3 C (102.7 F). Instead, he was forced to appear in a court hearing and is still being kept in a pre-trial detention cell with other detainees.

The situation in eastern Ukraine is even worse. Conditions in the detention centers in the DPR and LPR would test the strength of a healthy person in the best of times. The latest report on Ukraine by the U.N. Office of the High Commissioner for Human Rights (OHCHR) tells its own shocking story of intentional cruelty and neglect torture and ill-treatment including beatings, stress positions, electric shocks, asphyxiation, sexual violence, deprivation of water, food, sleep, or access to a toilet (para. 69).

Only recently, more than 100 civil society organizations worldwide appealed for international intervention to help prevent the spread of COVID-19 in the prisons of Ukraines occupied territories. Aside from these horrendous acts outlined by the U.N. human rights commissioner, cells lack light and are overcrowded, lack proper heating and sanitation, and are overflowing with sewage and vermin (including insects and rats). Ordinarily, detainees rely on their relatives for food and medication, but due to COVID-19 movement restrictions, family members are no longer able to access detention centers (see here and here).

In light of this systematic ill-treatment and the fact that ICRC and U.N. officials are still not provided access to detained persons held in official (let alone unacknowledged) detention centers, there is nothing to suggest that there will be any change in the near future, let alone anything resembling adequate medical protection from the spread of this pernicious infection.

Conclusion

There is little to suggest that Russia will accept or respect binding IHL obligations clearly mandating firm and decisive action to protect the health of populations in occupied Ukrainian territories. Indeed, the last five years of occupation have led to a range of IHL violations, some of which may amount to war crimes.

This rather gloomy assessment is not intended to inspire despair, but rather to reinforce the pressure that will be needed to achieve constructive change before it is too late. Common Article 1 of the Geneva Conventions, as interpreted by the International Court of Justice (see para. 158), requires every State Party, whether or not it is a party to a specific conflict, to ensure that the provisions of these instruments are complied with. As discussed above, Russia is obliged to provide adequate health care and medical supplies to the populations of Crimea and eastern Ukraine to counter the COVID-19 pandemic or, if unable to do so, reach agreements with other States or impartial organizations such as the ICRC to allow and facilitate the provision of appropriate medical assistance to these territories.

Compliance has its advantages for the Russian Federation as well. By strengthening its COVID-19 response and meeting its obligations under international law, Russia can avoid a full-blown epidemic within the territories it occupies. Not only would this be useful in the protection of its own territory from the coronavirus, it would also boost its credibility as part of the international community.

Time may be running out and, as we have seen throughout the world, action taken early and decisively remains the best protection against the spread of the virus and to ultimately save lives.

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Russia's Humanitarian Law Obligations to Civilians in Occupied Ukrainian Territories in the Time of COVID-19 - Just Security

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Merck Boosts Commercial Viral Vector and Gene Therapy Manufacturing Capacity – PR Newswire UK

Wednesday, April 22nd, 2020

"Viral vector manufacturing has transitioned from a niche industry to the cornerstone of the future of biopharmaceuticals," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "Few companies have the scale and quality systems in place for manufacturing commercial viral vector products. Building on our success in helping customers commercialize their gene therapies made possible by viral vectors, our expansion will help innovators produce at a scale that ensures these therapies reach more patients in need."

Merck's Life Science business sector facility in Carlsbad manufactures gene therapies for its customers globally. Gene therapy involves the delivery of a genetic payload into patient cells to produce a therapeutic effect such as correction of a mutated gene or retargeting of an immune cell to fight cancer. Diseases such as hemophiliaand cancer are being investigated using this technique where a single dose may cure the disease. Viral vectors are often called the most complex therapeutic manufactured today.The gene therapy market, which accounted for $1 billion in 2018, is expected to reach $10 billion by 2026, according to a recent Biotech Forecasts global market analysis and industry forecast.

Merck's new, 140,000-square-foot manufacturing facility will support viral and gene therapy production at the 1000-liter scale using its Mobius single-use equipment. The site is part of the Life Science business' expanding product and service offering to the viral and gene therapy marketplace. Merck has close to three decades of experience in cell and gene therapy, and its Carlsbad, California, U.S.A site has been involved in the gene therapy area since 1997, near the time that clinical trials for gene therapy began. In the interim, the company manufactured viral vectors for two cell and gene therapy products.

This expansion underscores Merck's continued investment in viral and gene therapies from clinical to commercial scale and marks the second major investment at its Carlsbad facility in recent years. In 2016, the investments resulted in nearly doubling its former production capacity. The upgraded facility grew from 44,000 square feet to 65,000 square feet. Today, the Carlsbad site is home to 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine and immunotherapy products. With the expansion, the company will add 11 suites, bringing the total to 27, used in various steps of manufacturing.

In addition to contract development and manufacturing services for viral vectors, Merck also provides seamless manufacturing and testing services at its pharma and biopharma testing sites globally.

Merck recognizes that cell and gene therapy has resulted in major advancements in medicine. The company supports these therapies under consideration of ethical and legal standards; it has established an independent, external Bioethics Advisory Panel. This panel provides guidance on various topics, including gene editing and stem cells usage, in which its businesses are involved. The company has also defined a clear operational position taking into account scientific and societal issues.

All Merck news releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About MerckMerck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck generated sales of 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Performance Materials.

Photo - https://mma.prnewswire.com/media/1156781/Merck_Gene_Therapy.jpg

SOURCE Merck

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Merck Boosts Commercial Viral Vector and Gene Therapy Manufacturing Capacity - PR Newswire UK

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Insights Into the $8.8 Billion Cell Therapy Industry, 2020-2027 – Rising Adoption of Regenerative Medicine, Introduction of Novel Platforms &…

Tuesday, March 17th, 2020

DUBLIN, March 11, 2020 /PRNewswire/ -- The "Cell Therapy Market Size, Share & Trends Analysis Report by Use-type (Research, Commercialized, Musculoskeletal Disorders), by Therapy Type (Autologous, Allogeneic), by Region, and Segment Forecasts, 2020 - 2027" report has been added to ResearchAndMarkets.com's offering.

The global cell therapy market size is expected to reach USD 8.8 billion by 2027 at a CAGR of 5.4%, over the forecast period.

Cellular therapies hold a great therapeutic promise across various clinical applications. This has resulted in substantial global investments in research and clinical translation. Moreover, rapid advances in stem cell research hold the potential to fulfill the unmet demand of pharmaceutical entities, biotech entities, and doctors in disease management. These factors have boosted revenue growth for the market.

Currently, there are a limited number of FDA-approved commercial stem and non-stem cell therapies in the market. Furthermore, LAVIV (Azficel-T), manufactured and commercialized by Fibrocell Technologies, witnessed revenue wind-down in the past years. Key developers are making substantial investments in the adoption of advanced technologies to address the aforementioned challenges.

The introduction of proprietary cell lines is recognized as the primary means by which a single cell can be exploited for the production of a robust portfolio of candidates. Companies are leveraging new technologies not only for the expansion of their product portfolio but also for establishing out-licensing or co-development agreements with other entities to support their product development programs.

For instance, MaxCyte has more than 40 high-value cellular therapy partnership programs within immune-oncology, regenerative medicine, and gene editing, including fifteen clinical-stage programs. Increase in the number of collaborations between entities for product commercialization is anticipated to accelerate market revenue to a major extent in the coming years.

In Asia-Pacific, the market is anticipated to witness significant growth over the forecast period. This is attributed to rising awareness cellular therapies among patients and healthcare entities in chronic disease management. In addition, availability of therapeutic treatment at lower prices is also driving the regional market. Japan is likely to witness fast growth over the forecast period attributed to increasing research activities on regenerative medicine.

Further key findings from the report suggest:

Key Topics Covered

Chapter 1 Executive Summary

Chapter 2 Research Methodology

Chapter 3 Cell Therapy Market Variables, Trends & Scope3.1 Market Segmentation & Scope3.1.1 Market driver analysis3.1.1.1 Rise in number of clinical studies pertaining to the development of cellular therapies3.1.1.2 Rising adoption of regenerative medicine3.1.1.3 Introduction of novel platforms and technologies3.1.2 Market restraint analysis3.1.2.1 Ethical concerns related to stem cell research3.1.2.2 Clinical issues pertaining to development & implementation of cell therapy3.1.2.2.1 Manufacturing issues3.1.2.2.2 Genetic instability3.1.2.2.3 Stem cell culture condition3.1.2.2.4 Stem cell distribution after transplant3.1.2.2.5 Immunological rejection3.1.2.2.6 Challenges associated with allogeneic mode of transplantation3.2 Penetration & Growth Prospect Mapping For Therapy Type, 20193.3 Cell Therapy Market (Stem & Non-stem Cells)-Swot Analysis, by Factor (Political & Legal, Economic and Technological)3.4 Industry Analysis - Porter's3.5 Cell Therapy Market (Stem & Non-stem Cells)-Regulatory Landscape

Chapter 4 Cell Therapy Market (Stem & Non-stem Cells) Categorization: Use-type Estimates & Trend Analysis4.1 Cell Therapy Market (Stem & Non-stem Cells): Use-type Movement Analysis4.2 Clinical-use4.3 Research-use

Chapter 5 Cell Therapy Market (Stem & Non-stem Cells) Categorization: Therapy Type Estimates & Trend Analysis5.1 Cell Therapy Market (Stem & Non-stem Cells): Therapy Type Movement Analysis5.2 Allogeneic Therapies5.3 Autologous Therapies

Chapter 6 Cell Therapy Market (Stem & Non-stem Cells) Categorization: Regional Estimates & Trend Analysis, by Product6.1 Cell Therapy Market (Stem & Non-stem Cells) Share by Regional, 2019 & 20276.2 North America6.3 Europe6.4 Asia-Pacific6.5 Latin America6.6 MEA

Chapter 7 Competitive Landscape7.1 Strategy Framework7.2 Company Profiles7.2.1 Kolon TissueGene, Inc.7.2.2 JCR Pharmaceuticals Co. Ltd.7.2.3 MEDIPOST7.2.4 Osiris Therapeutics, Inc.7.2.5 Stemedica Cell Technologies, Inc.7.2.6 Cells for Cells7.2.7 NuVasive, Inc.7.2.8 Fibrocell Science, Inc.7.2.9 Vericel Corporation7.2.10 Pharmicell Co. Ltd.7.2.11 Anterogen Co. Ltd.7.2.12 Celgene Corporation

For more information about this report visit https://www.researchandmarkets.com/r/ma559h

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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SOURCE Research and Markets

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Insights Into the $8.8 Billion Cell Therapy Industry, 2020-2027 - Rising Adoption of Regenerative Medicine, Introduction of Novel Platforms &...

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The tragic life of Meredith Vieira – Nicki Swift

Tuesday, March 17th, 2020

Meredith Vieira's husband,veteran journalist Richard Cohen, was diagnosed with multiple sclerosis at 25. His father and grandmother also suffered from the disease in what he called "a family illness" in a 2019 interview with Yahoo Lifestyle."I dropped a coffee pot for no reason. I fell off a curb for no reason. I noticed a little numbness in my leg," he explained. "I was very active physically and I thought I was really beating it. I was living in denial."

Cohen lived with the illness for ten years before meeting his future wife of 32 years, but he let her know immediately."She didn't blink," he told the outlet. Although he tried to keep his diagnosis hidden from everyone else, Cohen learned that keeping it a secret was not "a happy way to live." He now speaks to others "newly diagnosed with MS" to offer practical advice and emotional support. "You don't have to be controlled by it," he said. "I look at our three kids, I look at our relationship, I've written four books ... what do I have to complain about?"

During an interview with People, Vieira explained that they deal with Cohen's "chronic illness" by being able to "vent" to one another about the "limitations" it places on their relationship, but they choose not to "dwell" on them too long. "So many people are dealing with stuff and it puts it into perspective," she explained.

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The tragic life of Meredith Vieira - Nicki Swift

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The 411 on Stem Cells: What They Are and Why It’s Important to Be Educated – Legal Examiner

Thursday, February 20th, 2020

Medical treatment involving stem cells is an ever-growing, billion-dollar industry, so chances are you have heard about it in the news. Here in the U.S. and around the world, stem cells are being used in various therapies to treat a wide variety of health problems and diseases, including dementia, autism, multiple sclerosis, cerebral palsy, osteoarthritis, cancer, heart disease, Parkinsons disease, and spinal cord injury. Treatments for such health issues may sound promising, but the risk is many of those being sold and advertised arent yet proven to be safe and effective. This is why its so important to educate yourself before jumping into any kind of stem cell treatment.

To gain a better understanding of this new age of medical research, one must first understand what stem cells are and how they work. Stem cells are special human cells that can develop into many different types of cells. They can divide and produce more of the same type of stem cells, or they can turn into different functioning cells. There are no other types of cells in the body that have this natural ability to generate new cell types.

So where do stem cells that are used for research and medical treatments come from? The three main types of stem cells are embryonic (or pluripotent) stem cells, adult stem cells, and induced pluripotent stem cells.

Embryonic stem cells come from unused, in vitro fertilized embryos that are three to five days old. The embryos are only donated for research purposes with the informed consent of the donors. Embryonic stem cells are pluripotent, which means they can turn into any cell type in the body.

Adult stem cells are found in small numbers in developed tissues in different parts of the body, such as bone marrow, skin, and the brain. They are specific to a certain kind of tissue in the body and are limited to maintaining and repairing the tissue in which they are found. For example, liver stem cells can only make new liver tissue; they arent able to make new muscle tissue.

Induced pluripotent stem cells are another form of adult stem cells. These are stem cells that have been manipulated in a laboratory and reprogrammed to work like embryotic (or pluripotent) stem cells. While these altered adult stem cells dont appear to be clinically different from embryonic stem cells, research is still being conducted to determine if the effects they have on humans differ from actual embryonic stem cells.

Stem cells can also be found in amniotic fluid and umbilical cord blood. These stem cells have the ability to change into specialized cells like embryonic stem cells. While more research is being conducted to determine the potential of these types of stem cells, researchers already actively use these through amniocentesis procedures. In this procedure, the stem cells drawn from amniotic fluid samples of pregnant women can be screened for developmental abnormalities in a fetus.

The main difference between embryonic and adult stem cells is how they function. Embryonic stem cells are more versatile. Since they can divide into more stem cells or become any type of cell in the body, they can be used to regenerate or repair a variety of diseased tissue and organs. Adult stem cells only generate the types of cells from where they are taken from in the body.

The ability for stem cells to regenerate under the right conditions in the body or in a laboratory is why researchers and doctors have become so interested in studying them. Stem cell research is helping scientists and doctors to better understand how certain diseases occur, how to possibly generate healthy cells to replace diseased cells, and offer ways to test new drugs.

Clearly, stem cell research is showing great potential for understanding and treating a range of diseases and other health issues, but there is still a lot to learn. While there are some diseases that are showing success using stem cell treatments, many others are yet to be proven in clinical trials and should be considered highly experimental.

In our next article, various stem cell treatments, FDA regulations, and other stem cell hot topics will be explored. It will also focus on what to look for when considering stem cell therapies so people arent misled or misinformed about the benefits and risks.

For more information regarding the basics of stem cells visit these sites:

https://stemcells.nih.gov/info/basics/1.htm

https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117

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The 411 on Stem Cells: What They Are and Why It's Important to Be Educated - Legal Examiner

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The Challenge of Bioethics to Decision-Making in the UK – Westminster Abbey

Thursday, February 20th, 2020

Past Institute lectures

A lecture for the Von Hugel Institute series Ethics in Public Life, 5th February 2015, given by Claire Foster-Gilbert, Director, Westminster Abbey Institute.

The context of the series of lectures of which this is one is ethics in public life, and I would like to start by taking some time to describe the creation and operation of Westminster Abbey Institute, and use it as a prism for our consideration of bioethics and decision making in the UK. I want to say a little bit about the sacred-secular divide which I do not see. Then the two thorny examples I will use in bioethics, when I come to them, will be embryology and assisted dying.

Westminster Abbey Institute was launched in November 2013 to revitalize moral and spiritual values in public life, working with the public service institutions around Parliament Square, and drawing on its Benedictine resources of spirituality and scholarship.

Westminster Abbey sits on the south side of Parliament Square, with the Judiciary in the form of the Supreme Court on the west side, the Executive in the form of Whitehall on the north side, and the Legislature in the form of the Houses of Parliament on the east side. The Institute is the Abbeys answer to the question: what is it bringing to public service and how can it support those in public office?

We knew, when we started, what we were not: a think tank, part of the commentariat, a campaigning organisation, nor a fawning courtier. Nor were we apologists for religion in the public square. The Abbey is already more integrated than that. There is no sense of a sacred-secular divide, and as I go about my work as Director I feel none between my work and that of the public service institutions around the Square. The similarity is that we are identifying at the heart of the Parliament Square endeavour a sincere wish to support the good, to serve society, to make things better in the world. And in that sincere wish I see spirit moving, hearts opening, minds analysing, bodies acting, as a holistic, responsive flow to the call of public service.

I am not naive: the motivation to serve the public and the vocation to public service are not pure. In amongst the good wheat of service are the tares of motives such as selfish ambition, personal gain, fame, and the needy weakness of human nature to be recognised and rewarded. I see those other motives, but I know them for my own also, so am in no position the Abbey Institute is in no position, lets be clear to judge or condemn them. Like the parable, we leave that till the harvest. And meanwhile, by supporting the good, believing in the motives that are for service, recognising and applauding the rightness in the work around the Square, the murky tares, if I may torture the analogy beyond its capability, melt away. We hope.

I see a wholeness, then, responding to a call to serve. The deeper the response the more effective and lasting it will be and here is a place where our religion makes a specific contribution. The further back into God it reaches, the more effective and lasting and good the call to public service will be. I call it God. Spirit, depth, the swirling deep movement of creativity, the meditation of the soul, the rest before action. The further the archer draws back the bow, the further and truer the arrow will fly. It has been notable just how much of a longing for depth has shown itself in the people and institutions around the Square in the short time the Institute has been operating.

Our method is first to offer a Benedictine context. That is, we offer conversation that locates itself in stability, community and the conversion of manners. We will sit down with a group of, say, senior Civil Servants, or those tasked with offering professional development to MPs, or a group of Peers, and together we will devise a seminar for their department or group which will look at the good that the department or group is trying to do. What is significant and distinctive is that the psychological and philosophical location of the conversation is deep. That depth is also physically expressed by the Jerusalem Chamber where King Henry IV died and V became King, and the King James Version of the Bible was finalised, and so forth, where the seminars happen. Part of the Abbots and then the Deans lodging, a space where spiritual and worldly do not separate.

I was set a great example of how to do depth by Rowan Williams when he was the interlocutor for a series of four public conversations at St Pauls Cathedral, taking in turn global economy, ecology, governance and health, and asking the experts in those fields questions which immediately drew them into a consideration of the philosophical and even theological underlying currents of the subjects. The bishops did a similar thing with genetics experts when they spent a day learning about the subject. They were really good questions, and ones that practitioners, officials, public servants often dont have time to ask, but they are the most important questions because they lead us into our spiritual humanity.

A really lovely example emerged yesterday when we were sitting around the table in the Permanent Secretarys office of a Government Department, discussing a forthcoming seminar for the Department. One of the Civil Servants spoke about how too often officials in the Department will apply formulaic approaches, such as the benefit-cost ratio, in a way that masks or even undermines vital human qualities such as empathy and humility, and we will look at this in the seminar. Importantly, the words and the disposition came from the Civil Servant, not from the Abbey Institute. We are not functioning on the Square to tell others what the Good is. It emerges in the encounter.

So the conversation is located in a Benedictine place (in a way, for a short while, that Permanent Secretarys office became a Benedictine space). First, it is stable, it is safe here, and here is not going to go away, its an historical place where we can feel our own passing, gain a perspective on our place in history. Second, it is a place of community, which means that we are gathered in goodwill together, seeking the good together, united in our efforts and made companions in our purpose, not by any means agreeing with each other but feeling safe with each other. As a community of goodwill we feel it is safe to get things wrong, to take time to form conscience, to work things out. And of course we operate to the Chatham House rule. Third, we are about the conversion of manners. We expect transformation to take place though we dont necessarily know what it will be. Broadly, though, borrowing from Philip Shepherd, we will be looking for moves:

And I dont mind admitting that this transformation is probably only realised after the talking is over and everyone has gone to evensong and then wandered around the Abbey in the semidark and silence of the close of the day and had a glass of wine back in the Jerusalem Chamber!

In agreeing that we are a community of goodwill seeking to articulate the good I have offered an analogy from sailing that works well. A Government Department can be imagined as a sailing boat. At the helm stands the Permanent Secretary, who, like all good helmsmen, seeks never to steer the boat more than five degrees either side of the compass direction upon which the boat is set. Civil Servants in the Department form the crew, from the navigator who must know the course and ensure the helmsman anticipates obstacles, to the scrubber of decks who ensures no one slips up. All play their part in ensuring the boat remains shipshape and able to withstand the waves and the winds in travelling its appointed course.

The waves are the events of the nation and the world. They may be relatively calm or they may rise into steep and stormy mountains of water, threatening the stability of the boat.

The winds are public opinion, which can fill the sails of the boat and send it scudding on its chosen course. They can gust and buffet, interrupting the boats smooth journey. Or they can blow adversely, threatening to push the boat off course altogether.

Hence, the helmsman cannot simply hold the tiller fixedly. He or she must constantly respond and adjust to the wind and the waves, aiming to keep within five degrees either side of the compass direction or risk increasingly over-compensatory swings away from the course of travel.

The compass point towards which the boat is sailing is The Good. As such, it is not a destination; the journey is the thing, the direction of travel the concern, not the arrival.

By whom is The Good defined? It is true that the Government Minister is granted that responsibility and privilege by virtue of having been elected by universal franchise. But in defining The Good, Ministers have to have their Partys support. And of course the strength of the prevailing wind, public opinion, may be such as to determine a change of compass direction altogether. For the politician, public opinion will set parameters on what he or she can achieve. The great political leader will have a vision of the Good that transcends narrowminded concerns but retains Party support, and respects the parameters set by the prevailing wind of public opinion. The visionary and skilled politician will learn, quite possibly from his or her Civil Servants, about the art of tacking.

Because of course it is the helmsman and the crew who execute the tack, and any other sailing manoeuvres required. The Civil Service crew, having gathered the evidence sniffed the wind, watched the waves will need to be able to tell Ministers when their proposed direction of travel will not work: when, whatever the Ministers might want to think, their proposed direction is possibly not towards The Good. Thus the Good is sought by all.

And in passing, if one imagines Whitehall as a fleet of boats, those, too, will need to be taken into account by the helmsman. But and it is a wonderful sight sailing boats, journeying as a fleet in the same direction across the waves, subject to the same wind, stay uniform distances apart.

Having established a common concern with identifying the Good, seated in our Benedictine space, we then spend time as moral philosophers, looking at the specifics of the policy drivers for a given Government Department. Our analysis is rigorous, using the method I developed in the Centre of Medical Law and Ethics at Kings College, London, under Ian Kennedy, in the 1990s.

We use the three broad approaches that moral philosophers have taken over the centuries as they have sought to determine what is good. These we have called goal-based, duty-based and right-based, following Dworkinii, Botrosiii and Fosteriv. Very briefly and broadly, a goal-based thinker will see the good of an action in its consequences rather than in the content of the action itself; a duty-based thinker will look at the action and judge it according to preexisting moral rules; and a right-based thinker will judge the action according to the views of those most affected by it. The goal-based approach is valid insofar as it is the case that we rarely act without some end in view and it is right to consider whether that end is a good one. The goal-based approach is limited in that even very desirable goals should not justify actions which in themselves are intrinsically nasty. The ends are important moral considerations but they dont justify the means. Morality is not a mathematical exercise. The duty-based approach is valid in that it makes us think hard about what we are doing rather than merely why we are doing it, recalibrating the needle of our moral compass, making us morally sensitive rather than mathematically certain. The duty-based approach is limited because it can blind us to important consequences (Kant would have us truthfully respond to a murderer seeking her prey); and it is limited because it can make us arrogant: concerned only with our own place in heaven earned by doing the right thing, regardless of its effect or the views of others (the poor soul who will be murdered because Kant refused to tell a lie, or the patient who wants his life support switched off and we refuse to take a life). The right-based approach is valid because it requires us to listen to others, it makes us community-minded instead of purist. It is limited because on its own it would make someones request, for example, to take their life, right with no other consideration except that it is their wish.

All three approaches are needed. They conflict, they make us think, they require sensitive responses, honest appraisal, self-awareness because we will temperamentally favour one approach over the others, but taken together they form a three-legged stool that stands firm, if the legs are all of the same length, even on rocky ground.

And then comes the real challenge of bioethics. The Department of Health wants us all to live better for longer. But when does life begin and when does it end? I want in this third and final part of my lecture to explore the contemporary challenge of these questions by looking at two issues embryology and assisted dying that have been working their way around Parliament Square, with cases in the Supreme Court, policy development in Whitehall, and legislation or attempts at legislation in the Houses of Parliament.

Human fertilisation and embryology are scientifically complex and they are also, at every stage, morally sensitive. The challenge to Government and Parliament has been whether and how to draw these extraordinary scientific developments within a regulatory framework in a way that respects the science and does not ride roughshod over the sensitive moral questions, or ban the research and practice altogether. Having chosen the former course of action, what principles needed to underlie the regulatory framework?

Let us take a step back in time and thought. Let us bring the issue into our safe Benedictine space. Here we are allowed to think out aloud. We do not have to have a pre-determined position, but if we do, we wont be shouted down or assumed to be on the side of the devil.None need feel defensive. In this Benedictine space we are seeking the Good, aware that many have tried before us and God willing there will be many afterwards, all calibrating their moral compass and seeking to steer the boat no more than five degrees either side of the compass point, but having to allow, because of the wind of public opinion and the waves of ever changing events, that much leeway either side. We know we will not find perfect answers.

And now for the three-legged framework. From a goal-based perspective, we ask what embryology is for, and why it matters. Embryology is important as a cure for infertility, as a therapeutic response to currently incurable diseases using cell transplantation and, very recently proposed, eliminating mitochondrial disease altogether. Its goals, then, are for life: new life, and curing diseased life. No one, really, could argue with the goals of embryology. We would want the research and practice to be done excellently, so as to ensure these good goals were reached, but from a goal-based perspective, taken on its own, there can be no quarrel with it.

From a duty-based perspective, what does embryology involve? Here the moral questions start to bite. The first question must be about the status of the embryo itself. Because if the embryo has the same status as a human life, no matter how wonderful the goals are, no one would countenance destroying a human life to reach them, and embryology (which always involves destroying embryos) would fall at this moral fence.

The reasons you might regard the embryo as a human life are as follows: the embryo is formed from the fertilisation of an egg by a sperm forming a unique genome no one (if it is a person) was ever like it before, and no one will be ever again. We, each of us diverse people, were all embryos once. If we are to choose a point when life begins, the formation of the fertilised egg is certainly a definite stage one could choose.

The reasons you might not regard the embryo as human life are: the place of fertilisation is not the womb or the field in which the embryo is implanted, but at the base of the fallopian tubes. The embryo still has a journey to make to reach the womb and implant. (Some Shia teaching on this argues that life cannot be said to have begun until the seed, egg and field are all in place, ie at implantation.) During that journey, in the normal course of events, 70% of embryos do not reach the womb. It is during that journey that the all-important stem cells start to proliferate, hence the interest in the early, pre-implanted embryo, not the fetus in the womb. During that journey, the embryo may divide and become more than one fetus, hence genetically identical twins. These reasons may persuade you that it would be acceptable to see the early embryo not as human life but as potential life, and that its use therapeutically is acceptable. You may feel the goal-based tug: the status of the early embryo is in question, and the use of them therapeutically is so full of promise Should the duty-based consideration, that the embryo has independent moral status like that of a human being, give way?

What is important to recognise is that we do not say that the embryo has no status. The legislation has recognised its moral importance by regulating its use. But the law has accepted that the embryo is not the same as a human life.

From a right-based perspective, you cannot really make a judgement. The embryo cannot speak for itself. Is it fanciful to conduct a thought-and-feeling experiment predicated on the fact that we were all embryos once. Would we be happy to have been destroyed even before reaching the womb, to save another life or lives, or to create a new life? ??

The other right-based question relates to those who might benefit from stem cell or mitochondrial therapy: if they think of the embryo as having human status they may not want to benefit from such treatment. Healthcare practitioners may seek to be conscientious objectors.

The challenge to UK decision-making of embryology has been profound and I think, myself, that we have not done badly at it. Prior to this last development on mitochondrial DNA, the debates have been long and thoughtful, no speedy legislation was drawn up (except to prevent cloning), and the regulation is careful. In the UK, embryo research can take place but it is all regulated. (In the US, embryo research may not take place if it is federally funded; if you can pay for it yourself, you can do what you like!)

However, courts continue to be referred to as no legislation could possibly anticipate the science. It has turned out that the most fruitful source of embryonic stem cells has not come from embryos but from de-differentiated adult cells. Since however these de-differentiated cells, if placed in a womb, could theoretically grow into a clone of the person whose cell it was, this has had to be specifically outlawed and, much more recently, and potentially worryingly, a court has ruled that: The mere fact that a parthenogenetically activated human ovum commences a process of development is not sufficient for it to be regarded as a human embryo. This judgement opens the way to patenting the process of creating stem cells. It is potentially worrying since it arguably robs the embryo of its moral status. However, what is the status of a de-differentiated cell, which could originate from any one of the bodies in this room just by scraping our skin?

Is the very recent decision of the Commons to allow the process that removes diseased mitochondrial DNA from the offspring of mothers with the disease a case of slipping down a slippery slope into unethical waters? Is it the first step towards eugenics, since it eliminates the disease from the germ line permanently? Or is it an intelligent use of skills and techniques we have developed through carefully regulated embryo research, that will allow the cure of a vile disease?

Assisted dying, unlike embryo research, has not been made legal and given a set of regulations by which to abide. Despite its repeated return to Parliament and the apparent public support for a change in the law, none has happened, as yet. In practice, cases have been decided by the Courts and the number of cases coming to the Courts is only increasing. It is something of a sore point for the judges: they cannot turn cases away. All the time, as they see it, Parliament refuses to take the bull by the horn and create legislation, they are obliged to give judgements on a case by case basis that creepingly changes the law, and it is changed by lawyers not by democratically elected representatives of the public debating in public.

Before reflecting on the challenge to law and policy-makers that assisted dying has posed, let us once again step back into our Benedictine space, and we should pause here for a moment and recollect that the primary quality of that space is listening

And now conduct our analysis. Assisted dying is the act of making available to a person, who has expressly and competently asked for it, the means to take his or her life by their own hand.

From a goal-based perspective, one goal of assisted dying is to alleviate suffering. Another is torespect the autonomy of individuals. Another may be put more boldly: to end life deliberately.

From a duty-based perspective, principles of the sanctity of life and of respecting autonomy both raise their concerns, and conflict. How are they resolved?

From a right-based perspective, the principle of respect for autonomy trumps any duty of other individuals to save, sustain or end life. It is, simply, up to the individual. When polls are taken on the subject of assisted dying and euthanasia the vast majority of responses are in favour of it, on the grounds, though, that it is my life to do with as I please and who is any doctor to prevent me. But a law that permitted a solely right-based approach that the request should be granted simply because it had been made would be impossible to apply. It would be impossible to know if the person had actually asked for death, because they would be dead. Additional safeguards have to be included in any legislation, and these require that certain relevant professionals are satisfied that the conditions allowing assisted dying are met. This is not, then, a purely rights-based activity any more. Similar difficulties arise in seeking abortion - it is not, in the legislations, simply up to the mother whether or not the abortion takes place. She has to satisfy two doctors that she fulfils the criteria set by the law. The fact that doctors will very often sign the forms without questioning the mother, because they take a right-based approach in profoundly believing in her right to choose, is symptomatic of the challenge of lawmaking in areas of bioethics.

If the dying in question is assisted only, ie the person has to take the lethal substance themselves, this right-based problem is allayed. That is to say, we may be fairly sure that if the pink drink given by organisations such as Dignitas is drunk without assistance once it is put in the hands of the one seeking assisted dying, then he or she most definitely did want to die.

We cannot know what passes in their hearts however, and Mary Warnock has been worryingly at ease with the idea that it would be perfectly all right to seek euthanasia on the grounds that one felt a burden to ones family and friends. The wishes and needs of the community of that individual: family, loved ones, society are all included in the right-based approach, and what of these? Chaplains ministering to those receiving euthanasia in Holland speak of the devastation of families, resonant of the desolation of the families of suicides.

The most recent case that came to the Supreme Court was that of Nicklinson, Lamb and the Director of Public Prosecutionv. Nicklinson and Lamb were both almost entirely paralysed; Nicklinson from a stroke which left him able to blink only and Lamb from an accident that meant he could only move his right hand. Hence neither would be able to take the pink drink unaided, so both wished to be assisted to die without fear of prosecution of those who helped. The Director of Public Prosecution sought the freedom to decide on the matter of assisting suicide on a case by case basis.

In the Supreme Court, all the Law Lords agreed that Article 8 of the Human Rights Act (which is the right to a private life, to be overridden only in the case of threats to public safety or criminal acts) is relevant to the issue of assisting someone to die if it is their express wish. That is to say, domestic rulings can be made by way of interpretation of the Article in relation to assisted suicide. But while some Law Lords believed that it was a right for a person to be assisted to die if it was their express wish, according to Article 8, others did not. It was recognised that there was a fundamental incompatibility between the sanctity of life and autonomy. Several Law Lords argued strongly that the debate should be held in Parliament as the representative body of society, not judged upon by appointed Justices. And indeed there is yet another bill to allow assisted dying making its way through the House of Lords now. It has reached the stage where the Lords are working through more than 100 amendments, some of which are clearly intended to wreck the bill, whilst others provide clarification and strengthening of safeguards. And arguably the intellectual purity of the moral reasoning of the judges is a better place to turn to than the mess of Parliamentary debate. What a strange way for law on such a sensitive and controversial issue as the management of the dying process to be written: by the tug of war of differing factions and the compromise that will inevitably be reached if the bill is to succeed.

And yet, how are we to decide these matters that affect us all? I should like to finish, provocatively, with a lengthy quotation from a recent lecture delivered by one of the Justices of the Supreme Court, Lord Sumption.

To sum up, then. We have considered challenging and complex bioethical issues using the Westminster Abbey Institute approach of first, creating a Benedictine space of safety and stability, second, subjecting the matter to rigorous moral analysis and third, coming to a decision, which decisionmaking is the responsibility of the lawmakers and the policymakers. What I have not done is to offer absolute rules or principles which trump every other consideration. It is far better to be morally sensitive than to be morally certain. And so I am agreeing with Lord Sumption that, however fallible it may be, Parliament is the place to fashion legislation on these matters. We do well to attend to whom we put there.

(i) Philip Shepherd, New Self, New World: recovering our senses in the twenty-first century, (Berkeley: North Atlantic Books), 2010 (p 282)(ii) Ronald Dworkin, Taking Rights Seriously, 1977 (Harvard: Harvard University Press)(iii) Sophie Botros and Claire Foster, The moral responsibilities of research ethics committees, in Dispatches, 3:3, Summer 1993(iv) Claire Foster, The Ethics of Medical Research on Humans, (Cambridge: Cambridge University Press) 2001(v)R (on the application of Nicklinson and another) (Appellants) v Ministry of Justice (Respondent); R (on the application of AM) (AP) (Respondent) v The Director of Public Prosecutions (Appellant); R (on the application of AM) (AP) (Respondent) v The Director of Public Prosecutions (Appellant) 25 June 2014(vi) Lord Sumption, The Limits of Law, 27th Sultan Azlan Shah Lecture, Kuala Lumpur, 20 November 2013

Download a transcript of this lecture (PDF, 238KB)

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The Challenge of Bioethics to Decision-Making in the UK - Westminster Abbey

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Penn announces seven 2020 Thouron Award winners – Penn: Office of University Communications

Thursday, February 20th, 2020

Four University of Pennsylvania seniors and three recent alumni have won a Thouron Award to pursue graduate studies in the United Kingdom. Each scholarship winner receives tuition for as long as two years, as well as travel and living stipends, to earn a graduate degree there.

Established in 1960 and supported with gifts by the late John Thouron and his wife, Esther du Pont Thouron, the Thouron Award is a graduate exchange program between Penn and U.K. universities that aims to improve understanding and relations between the two countries.

Penns seven 2020 Thouron Scholars are:

Daniel Brennan

Senior Daniel Brennan, of Miami, is a varsity oarsmen for Penns lightweight crew team majoring in history and political science, with concentrations in military history and political theory in the School of Arts and Sciences. As a United States Marine and past moderator of the Universitys Philomathean Society, he is an advocate for greater civil-military awareness. Brennan works on national security policy as a Student Fellow at the Perry World House and is writing his honors thesis on the development of counterinsurgency strategy during the Cuban War of Independence. He is a Benjamin Franklin Scholar and has worked on anti-hunger issues both as a Fox Leadership Fellow with the Catholic Archdiocese of Philadelphia and by organizing his crew teams meal-packing events. In the U.K., he plans to pursue a masters degree in military history.

Braden Cordivari

Braden Cordivari, of Elverson, Pennsylvania, is a 2018 graduate of the College of Arts and Sciences. He received his bachelors degree in classical studies and anthropology with a minor in archaeological science. Since 2015, he has continued to work at Penns excavations at the ancient Iron Age city of Gordion in Turkey. He spent the 2018-19 academic year as a John Williams White Fellow at the American School of Classical Studies at Athens completing a program of intensive study of Greek archaeology and history. His research interests include human/environment relationships in the past and the study of craft production through science-based methods. Cordivari plans to pursue a masters degree in archaeological science at the University of Cambridge.

Gregory Forkin

Gregory Forkin, of Philadelphia, is a 2019 graduate with a bachelors degree in mathematics, physics, and biology and a minor in chemistry. He was a University Scholar and a member of Phi Beta Kappa. Currently, he is conducting research in neuroscience under Professor Vijay Balasubramanian and is a teaching assistant in the Math Department in the School of Arts and Sciences. Forkin plans to pursue a masters degree in pure mathematics at the University of Cambridge.

Natasha Menon

Senior Natasha Menon, of Scottsdale, Arizona, is pursuing a major in philosophy, politics, and economics with a concentration in distributive justice and a minor in legal studies and history in the School of Arts and Sciences. Menon serves as president of the Undergraduate Assembly, through which she works to elevate the voices of marginalized communities on campus to effect change. She is also a Civic Scholar, and has volunteered at Moder Patshala, a Bangladeshi immigrant services center in Philadelphia, for three years. Menon plans to pursue a masters degree in international migration and public policy at the London School of Economics. Upon returning to the U.S., she hopes to pursue a law degree and engage in public service in Arizona.

Robert Subtirelu

Senior Robert Subtirelu, from Ronkonkoma, New York, is majoring in the biological basis of behavior and minoring in chemistry in the School of Arts and Sciences. A recipient of the 2019 Clinical and Translational Research Award, he has conducted research with the Perelman School of Medicines Department of Neurosurgery to investigate post-traumatic epilepsy. He works as a teaching assistant, volunteers with Wissahickon Hospice, and remains an active member of Penns Medical Emergency Response Team. He also founded and coordinated the activities of a not-for-profit organization that has established educational and nutritional programs internationally. Subtirelu plans to pursue a masters degree in clinical and therapeutic neuroscience at the University of Oxford.

Zachary Whitlock

Senior Zachary Whitlock, of Washington, D.C., is in the Vagelos Integrated Program in Energy Researchjoint-degree program, majoring in materials science and engineering in the School of Engineering and Applied Science and in earth science in the School of Arts and Sciences. Whitlock has workedon biomimetic functional materialswith Penn Engineerings Shu Yang Laboratory and internationally at the French Alternative Energies and Atomic Energy Commission. More recently, he worked at the intersection of industrial materials and environmental impact on the Kleinman Center for Energy Policy-funded project Fossil Fuels, the Building Industry, and Human Health. He is a 2020 Kleinman Undergraduate Fellow and Supported Student at the Water Center at Penn. He is planning to pursue a masters degree in environmental systems engineering at University College London and ultimately hopes to contribute to the sustainability and impact mitigation of projects reliant on ecosystem services.

Maia Yoshida

Maia Yoshida, of Madison, New Jersey, received her bachelors degree in 2018 in molecular and cell biology with a minor in fine arts. She is now a researcher in a bioengineering lab, engineering immune cells to better fight cancers. While at Penn, she researched the molecular mechanisms involved in neurodegenerative diseases and was a teaching assistant for a fine arts course on biological design. She also taught elementary school science at the Penn Alexander School in West Philadelphia. As the president of Global Brigades at Penn, she led fundraising efforts for sustainable development projects in Honduras. Yoshida plans to pursue a masters degree in STEM Education at Kings College London.

TheCenter for Undergraduate Research and Fellowshipsserves as Penns primary information hub and support office for students and alumni applying for major grants and fellowships, including the Thouron Award.

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Penn announces seven 2020 Thouron Award winners - Penn: Office of University Communications

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BrainStorm Cell Therapeutics to Present at the 2020 Biotech Showcase and 3rd Annual Neuroscience Innovation Forum at JPM Week – GlobeNewswire

Tuesday, January 7th, 2020

NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Chaim Lebovits, President and Chief Executive Officer, will provide a corporate overview at the 2020 Biotech Showcase, being held on January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California.

Mr. Lebovits will also present at the 3rd Annual Neuroscience Innovation Forum, taking place on January 12, 2020, at the Marines Memorial Club in San Francisco. Additionally, Ralph Kern M.D., MHSc, BrainStorms Chief Operating Officer and Chief Medical Officer, will participate on aRare & Orphan Diseases Panel.

Meetings

BrainStorms senior management will also be hosting institutional investor and partnering meetings at the 2020 Biotech Showcase conference (https://goo.gl/SGFm62). Please use the Investor contact information provided below to schedule a meeting.

About NurOwn

NurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at http://www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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BrainStorm Cell Therapeutics to Present at the 2020 Biotech Showcase and 3rd Annual Neuroscience Innovation Forum at JPM Week - GlobeNewswire

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Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 – JD Supra

Saturday, December 21st, 2019

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA teams second year-end post will provide an overview of 2019 with a focus on the drug, biologic, and regenerative medicine programs at the agency. In many ways, the past year could be called a business as usual year for the FDAs drugs and biologics centers in that they continued to make progress on all of large-scale programs and priorities initiated by former-Commissioner Scott Gottlieb, who left the agency in April. FDA has been under the leadership of an Acting Commissioner since that time, although Texas radiation oncologist Dr. Stephen Hahn will be taking the reins soon following his confirmation by the full Senate in a 72-18 vote on December 12, 2019. (The Senate HELP Committee advanced the nominee on December 3, 2019; see our blog post just prior to that committee vote here.)

At the same time, however, the final months of 2019 have exposed several challenges for various FDA programs that operate under the extensive drug and biologic authorities contained in the Food Drug & Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), respectively. The agency will be forced to grapple with many of these issues directly and deliberately in 2020as a result of deadlines of the agencys own making as well as external pressures coming from other parts of D.C. and from the rapidly changing nature of the U.S. health care system.

Business as Usual When Getting New Drugs, Generic Drugs, and Biosimilars to Market and Promoting Competition under Various Action Plans But Challenges Are Emerging Related to Accelerated Approval and Breakthrough Products

According to data presented by the Office of New Drugs in early December (see ONDs slides here), FDA had another extremely productive year when it comes to its approval of new molecular entities that address a unique blend of therapeutic areas. The agency approved 45 new molecular entities in FY 2019 (October1, 2018 to September30, 2019), of which 71%, or 32 products, received priority review status and 23 were designated as orphan drugs intended to treat rare diseases. As OND emphasized in the presentation, several of those new product approvals are notable for their uniqueness and therefore, in the agencys view, 2019 reflects not only quantity but [also] quality. The OND presentation also highlights a significant amount of other information on new molecular entity approvals and may be of interest to those readers who want to take a deeper dive into the data.

In addition to advancing important new drugs and biologics to market, former Commissioner Gottlieb is well-known for having spearheaded to development of a Drug Competition Action Plan (DCAP) and a Biosimilars Action Plan (BAP) during his nearly two-year tenure as head of the agency. Some of our prior coverage of the DCAP and BAP is available here. In general terms, the DCAP encourages market competition for generic drugs and helps to bring greater efficiency and transparency to the generic drug review process; the BAP aims to achieve similar goals for biosimilar products as the agency continues its implementation of the 2010 Biologics Price Competition and Innovation Act (BPCIA), including the critical drug-to-biologic transition that will occur by operation of law in March of 2020.

FDA continued to make progress on its various goals under these two initiatives during 2019. Some examples of this progress can be captured with these two data points:

With all of these wins, however, FDA still faces its fair share of challenges related to its expedited drug and biologic programs, especially as it appears to have accelerated its review of products intended for diseases with an unmet need to breakneck speed. Indeed, the OND presentation from early December also added that for FY 2020 and as of November 21, 2019, the agency had already approved 13 such drugs, suggesting that next year could be a record-breaking one in terms of innovative drug product approvals. A recent Bloomberg Law article (available here) used the phrase breakneck speed to describe the agencys actions in this space based on several recent FDA approvals of new molecular entities that have come months in advance of their assigned target dates. The Bloomberg Law article highlights that in response to FDAs speediness in reaching approval decisions on new drugs and biologics for diseases with unmet needs, patient advocates and, increasingly, insurers that have to pay for those treatments are starting to raise concerns that these products lack sufficient safety or effectiveness data.

Relatedly, there has been increasing pressure on FDA to remove certain accelerated approval drugs from the market following a failure by the drug product sponsor to confirm the efficacy or clinical benefits of the product in the required post-marketing confirmatory clinical trial. The most visible example of this regulatory challenge came in October 2019 when FDA convened an advisory committee to recommend whether it should withdraw accelerated approval from hydroxyprogesterone caproate injection (marketed under the brand name Makena for the prevention of preterm birth in pregnant women). FDAs Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval, with the dissenters favoring leaving Makena on the market while requiring the sponsor to conduct a new confirmatory trial. (Notably, no one voted for the option of leaving it on the market without requiring a new confirmatory trial.)Among the concerns of some members who voted to leave the product on the market with a new clinical trial obligation was that the drugs withdrawal would leave no safe treatment options for pregnant women at high risk of preterm birth. FDA will have to make a final decision regarding what to do about Makena in 2020, and it undoubtedly will face intense criticism (and potentially legal challenge) no matter what route it chooses to take for this public health quandary in which it finds itself.

In a similar vein, FDA official Dr. Richard Pazdur participated in a Senate briefing on December 10, 2019, in which he and other speakers defended the Breakthrough Therapy Designation program. FDA insisted again that the designation was intended to let the agency have earlier interactions with drug sponsorsand that it was not meant to be an early rating system for drugs or a signal of how they might do commercially. Given that the Breakthrough program was created in 2012 and is considered to be wildly successful, some speakers at the briefing expressed surprise that there was still any confusion about its purpose and function. Whether Congress picks up any of these emerging areas for consideration as part of FDAs 2022 user fee reauthorization packages remains to be seenas those negotiations will begin in earnest after the New Year, but the issues certainly are complex enough to allow for robust policy discussions to occur.

Finally, there are expected to be bumps in the road with the upcoming March 2020 transition of proteins previously approved under New Drug Applications (NDAs) to Biologics License Applications (BLAs)for which FDA only finalized its guidance for industry last year. The March 2020 transition date was established under the BPCIA and the agency does not have discretion in getting the transition done (only in how it handles the logistical and administrative issues created by transitioning approved products in this way). Check out our prior blog post on the final deemed to be a license transition guidance.

Business as Usual with the Rapid Pace of FDAs Issuance of Agency Guidance But Challenges Are Emerging Related to Judicial Deference to FDA Decision-Making

FDA guidance documents for all regulated product categories continued to be released on a regular basis this year, including several related to areas of agency priorities under the DCAP and BAP including the final biosimilar interchangeability guidance issued in May (see our blog post here) and a draft guidance on insulin interchangeability issued in November 2019. The latter also relates to the March 2020 NDA-to-BLA transition, as insulins are one of the largest class of products that will be transitioning into regulation as biologics, making them open to what is expected to be more efficient competition through the BPCIAs biosimilar pathway than what was possible in the past as insulin NDAs.

Despite the accelerated pace of the issuance of Agency guidance, however, FDA is beginning to face more challenges related to its decision-making and the scope of its exercise of agency discretion. In particular, a significant District Court for the District of Columbia ruling issued on December 6, 2019, Genus Medical Technologies, LLC v. FDA, provides hints of a potential shift in judicial deference to certain agency actions. The court vacated FDAs classification of a medical imaging liquid as a drug rather than as a device after determining that FDA did not have discretion to decide how to regulate a product merely because the definitions of drug and device overlap in the FD&C Act.

According to the district court judge, FDA was not interpreting the drug/device definitions in the statute properly, and Congress did not intend to allow the agency unfettered discretion to pick between the two categories. Rather, the court found that the text of the definitions are clear and do not create a gap or any ambiguity for FDA to fill with an exercise of agency discretion. This recently issued decision may indicate a potential shift in how courts are going to apply long-standing precedents related to judicial deference to agency decisions. If FDA decides to appeal the Genus ruling, it may end up at the Supreme Court as one of many expected challenges to the doctrines that established our current framework for judicial deference of an administrative agencys interpretation of an ambiguous statute.

Business as Usual with FDAs Comprehensive Regenerative Medicine Framework and Stepped up Enforcement Against Stem Cell Clinics Offering Unlawful Products But What Happens in November 2020 When the Enforcement Discretion Period Ends?

One of the first FDA press releases for 2019 was co-authored by former Commissioner Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks and was focused on the agencys new policies aiming to advance the development of safe and effective cell and gene therapies. In the press release, the agency leaders predicted that by 2020, FDA would receive more than 200 Investigational New Drug Applications (INDs) for cell and gene therapies each year. The agency has continued to work diligently to increase its staff in CBER to conduct clinical reviews for such INDs and to try to keep pace with the industrys development of these innovative technologies.

As we discussed in our update on FDAs Comprehensive Regenerative Medicine Policy Framework earlier this year, the agency is prioritizing two parallel goals: (1) clarifying the regulatory criteria for product marketing and providing support and guidance to legitimate product developers; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market. The second prong of this comprehensive plan for regenerative medicine products was the topic of one of Dr. Gottliebs very last statements as Commissioner before he left the agency, issued on April 3, 2019 in conjunction with CBER Director Dr. Marks, indicating how important this area is to the agencys current public health priorities.

In the April 2019 statement, Drs. Gottlieb and Marks acknowledged FDAs challenges and efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, citing several Warning Letters issued to manufacturers that violated current good manufacturing practices (CGMPs) for human cells and tissue products. They noted that it was of particular concern given that the industry was nearly halfway through the period during which the FDA intends to exercise enforcement discretion for certain regenerative medicine products with respect to INDs and premarket approval requirements. Now that it is December 2019, that deadline is even closer with less than one year left. November 2020 is the end of the three-year period of enforcement discretion announced by FDA when it first articulated the policies and goals of this comprehensive framework in 2017. See our prior posts on the topic here and here.

Under the Comprehensive Regenerative Medicine Policy Framework, FDA appears to have stepped up the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019. In conjunction with a Warning Letter issued on December 5, 2019 to two related companies for processing and marketing unapproved umbilical cord blood-derived cellular products, Dr. Marks of CBER reiterated the agencys concerns about safety and reminded the public of the upcoming compliance deadline: As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the [FD&C Act] and FDAs regulations.

Dr. Marks was referring to two Untitled Letters that were issued to stem cell product distributors on November 20 and November 25, 2019, respectively. The press release cited above also added that the agency had also recently sent 20 letters to manufacturers and health care providers noting that it has come to [FDAs] attention that they may be offering unapproved stem cell products, reiterating the FDAs compliance and enforcement policy.

FDA also prevailed this year in the U.S. District Court of the Southern District of Florida against a stem cell clinic charged with violating the FD&C Act and the PHS Act. In June 2019, the court held that the defendants adulterated and misbranded a stem cell drug product made from a patients adipose tissue without FDA approval and for significant deviations from CGMPs, issuing a permanent injunction as requested by the Department of Justice on FDAs behalf. The agencys statement on that important court win by the government is available here.

Lastly, on December 6, 2019, FDA issued a Public Safety Notification on Exosome Products. The safety notification informed the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes, which came to FDAs attention through the Centers for Disease Control and Prevention, the Nebraska Department of Health and Human Services, and others. There are currently no FDA-approved exosome products and, to be honest, we are not even sure what such a product would be since an exome consists of all the sequenced exons within a single human genome after the introns are removed. (So were the clinics administering complete exomes to patients? that seems unlikely.)But what we found noteworthy about this public safety notice is the forceful and direct language FDA used when describing the unscrupulous conduct of the sellers of these products:

Certain clinics across the country, including some that manufacture or market violative stem cell products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that they these products do not fall under the regulatory provisions for drugs and biological products that is simply untrue. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the [PHS Act] and the [FD&C Act] and are subject to premarket review and approval requirements.

The clinics currently offering these products outside of FDAs review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.

As we enter the final year of FDAs enforcement discretion period, perhaps these public notices and Warning/Untitled Letters will become even more frequent and the agency will become even more frustrated by the ongoing violations and medical practitioners who flout federal law. This area will see substantial activity in 2020 and we will be watching closely to see what changes, if anything, about FDAs approach in November when the deadline to come into compliance ends. Will there be widespread FBI raids on stem cell clinics engaged in this kind of bad behavior? Only time will tell.

Final Thoughts: A Few Other Business as Usual Activities in the Therapeutic Product Areas and Prescription Drug Advertising Enforcement

Although we have highlighted what we view as some important challenges for the FDA to address in the coming months, other areas continue to be business as usual without anything very new to report. FDA continues to invest significant resources into improving the quality of compounded drugs and ensuring compliance with Sections 503A and 503B of the FD&C Act. Drug compounding was another topic of one of Dr. Gottliebs very last statements as Commissioner on April 3, 2019, in which he laid out the 2019 compounding priorities that included maintaining quality manufacturing and compliance and regulating compounding from bulk drug substances.

Notwithstanding all the efforts by FDA and State regulators in this area over the past several years, the agency continues to see concerning activity when it comes to compounded drugs, such as problems related to the condition under which compounded sterile medicines are made, which raisesignificant risks to patients. As a result, FDA has made it an intense area of focus to take enforcement actions against compounders who fail to produce sterile drugs in compliance with the law. During the past year, for example, FDA has won at least four permanent injunctions against various compounders after the agency identified behavior that posed a significant risk to public health and safety.

In addition, in 2019 FDA also increased its activities towards reducing and mitigating the impact of drug shortages on the health care system. See our prior blog post on Drug Shortages.

Finally, after a fairly slow year of enforcement in the prescription drug advertising space, the last two months of 2019, at least as of December 12th, have given us three (!) letters two untitled and one warning from the FDAs Office of Prescription Drug Promotion (OPDP). Most interestingly, the Warning Letter issued on December 2, 2019 for omitting warnings about the most serious risks associated with [a medication-assisted treatment] drug from promotional materials was announced to the public via FDA press release, which is not a typical action for normal-course OPDP letters to industry. The drug in question, approved for the prevention of relapse to opioid dependence following opioid detoxification, is associated with several significant risks including potential opioid overdose. Given the countrys public health emergency that is the opioid epidemic, FDA appears to have felt the need to make the deficiencies in the advertisement and those risks more widely publicized. So another thing we will be watching for in the New Year is whether this OPDP action represents the beginning of a new trend by the agency to publicize these Warning Letters more directly, or whether its advertising enforcement activities may be picking up due to industrys evolving approaches to promoting therapeutic products.

If you made it to the end of this post, thank you for reading our tome, and we hope you found it helpful and interesting! Stay tuned next week for our third and final FDA year-end blog post.

[View source.]

Link:
Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 - JD Supra

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Edited Transcript of MRKR.OQ earnings conference call or presentation 12-Nov-19 10:00pm GMT – Yahoo Finance

Friday, November 29th, 2019

Nov 29, 2019 (Thomson StreetEvents) -- Edited Transcript of Marker Therapeutics Inc earnings conference call or presentation Tuesday, November 12, 2019 at 10:00:00pm GMT

* Anthony H. Kim

Marker Therapeutics, Inc. - CFO

Marker Therapeutics, Inc. - SVP of Clinical Development

* Peter L. Hoang

Marker Therapeutics, Inc. - President, CEO & Director

Roth Capital Partners, LLC, Research Division - MD, Senior Equity Analyst & Head of Biotechnology Research

Nomura Securities Co. Ltd., Research Division - Research Analyst

Oppenheimer & Co. Inc., Research Division - Associate

Janney Montgomery Scott LLC, Research Division - Equity Research Analyst & Director of Biotechnology Research

Greetings, and welcome to the Marker Therapeutics Third Quarter 2019 Operating and Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to our host, Tony Kim, Chief Financial Officer. Thank you. You may begin.

Anthony H. Kim, Marker Therapeutics, Inc. - CFO [2]

Thank you, and welcome, everyone, to our third quarter 2019 earnings call. The press release reporting our financial results is available in the News section of our corporate website at markertherapeutics.com. Joining me for the call today are Peter Hoang, our President and Chief Executive Officer; Dr. Juan Vera, Chief Development Officer; and Dr. Mythili Koneru, Senior Vice President of Clinical Development.

As a reminder, we will be making forward-looking statements during today's call. These statements are subject to risks and uncertainties that may cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-Q on file with the SEC.

I would now like to turn the call over to Peter Hoang.

Peter L. Hoang, Marker Therapeutics, Inc. - President, CEO & Director [3]

Thank you, Tony. Good afternoon, everyone, and thanks for joining us.

We continue to make progress advancing our MultiTAA T cell therapies across various hematologic and solid tumor cancers in the quarter. In ongoing partner-sponsored clinical studies with MultiTAA T cells at Baylor College of Medicine, patients are experiencing durable responses, some over 5 years, with virtually no meaningful treatment-related toxicities. And while it's early days, we are encouraged by the promising results delivered by our novel T-cell immunotherapy particularly in such challenging disease areas.

In anticipation and support of future Marker-sponsored clinical trials, we continue to build out our infrastructure and expand our team. We anticipate the next 12 to 18 months to be an exciting and productive time for our company.

As you may recall, based on the breadth of data collected across the Baylor-sponsored studies, we have selected acute myeloid leukemia, or AML, as our lead indication for our first company-sponsored clinical trial. We recently filed a new Investigational New Drug application, or IND, with the U.S. FDA as part of a planned Marker Phase II study in post-allogeneic hematopoietic stem cell transplant patients with AML in both the adjuvant and active disease settings. Upon reviewing our submission, the FDA requested additional information regarding certain quality and technical specifications for 2 reagents supplied by third-party vendors that are used in our manufacturing process. These reagents are ancillary products used in manufacturing and are not present in the final product. However, because the data are needed to clear the IND, the trial has been placed on hold until our complete response to the technical questions is deemed satisfactory to the FDA.

Because the agency's questions were directed to third-party products rather than our own process or product, we worked with the regulatory and quality groups at the respective manufacturers to address the FDA's request. After receiving the required information from them, we submitted our complete response to the agency in late October, and regulators have 30 days to respond. We will communicate an update and our plans to move forward once these questions have been addressed. Given the various resolution scenarios, we are confident that we can initiate the trial in 2020 and hope to provide more precise time lines later this year.

We recognize the need for new, improved therapies in AML. And advancing our novel T-cell candidate, which we believe can have a significant impact on the treatment of this patient population, remains our top priority. In fact, AML is the most common acute leukemia in adults and progresses rapidly without treatment. The prognosis for these patients is poor with a 5-year survival rate of 28% and a high risk of relapse necessitating the need for improved treatments. Current options are mostly limited to chemotherapy, sometimes in combination with a bone marrow transplant. Both treatments carry a risk of bleeding, life-threatening infections and permanent infertility. Bone marrow transplants also carry risk of graft-versus-host disease, also known as GVHD.

We believe that our MultiTAA therapy may have several advantages over standard approaches as well as other T cell therapies in development. In contrast to monospecific T cells, MultiTAA T cells recognize up to 5 antigens and allow for epitope spreading, leading to a more potent, durable antitumor response. And unlike transplants that require hospital stays, MultiTAA is administered in an outpatient setting.

MultiTAA-based cell therapy is our central focus, but we are also advancing several legacy vaccine-based programs. To date, clinical results in our breast cancer trials have showed continuing progress, including, based on a preliminary analysis of 34 patients enrolled in a triple-negative breast cancer trial to date, 31 have showed meaningful immune responses to vaccine treatment. Of 80 patients treated at 11 clinical sites, 14 have shown disease progression as of September 30, 2019, following treatment with TPIV200.

We have, however, made the decision to discontinue the development of our cancer vaccine in patients with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from our Phase II study conducted by an independent Data and Safety Monitoring Board, or DSMB. Although the DSMB did not express any safety concerns with respect to TPIV200, we have elected to suspend the trial as it did not meet our threshold for probability of success based upon our prespecified criteria. Pending full review of the data, we anticipate closing the trial in the first quarter of 2020.

Unlike the ovarian cancer trial, there is no formal interim analysis in the breast cancer trial. The last patient will complete the trial in Q2 2021, at which time we will communicate the results and make a decision on next steps for that product.

With that, I will turn the call over to Tony to review financials. After that, we look forward to taking your questions.

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Anthony H. Kim, Marker Therapeutics, Inc. - CFO [4]

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Thanks, Peter. Net loss for the quarter ended September 30, 2019, was $5.5 million compared to a net loss of $4.4 million for the quarter ended September 30, 2018.

Research and development costs during the 3 months ended September 30, 2019, was $3.1 million compared to $1.9 million during the 3 months ended September 30, 2018. The increase of $1.2 million was primarily attributable to increases in personnel-related expenses relating to the buildup of our internal infrastructure.

General and administrative expenses were $2.5 million during the 3 months ended September 30, 2019, as compared to $2.6 million during the 3 months ended September 30, 2018. The decrease was primarily attributable to $0.6 million of merger-related expenses incurred during the 3 months ended September 30, 2018, offset by increased expenses in head count-related legal and other professional expenses.

I will now turn the presentation back over to Peter for final remarks.

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Peter L. Hoang, Marker Therapeutics, Inc. - President, CEO & Director [5]

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Thanks, Tony. I'll open the call for questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Christopher Marai with Nomura Instinet.

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Jackson Dean Harvey, Nomura Securities Co. Ltd., Research Division - Research Analyst [2]

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This is Jackson Harvey on for Christopher Marai. I'm just curious, after the FDA resolves the clinical hold with the response to their technical concerns, how quickly will you be able to start dosing patients?

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Peter L. Hoang, Marker Therapeutics, Inc. - President, CEO & Director [3]

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Thanks for the question. That's a great question. We've not stood still in the meantime. In fact, I think that preparations for initiation of the trial are fully underway. In fact, we're progressing ahead of plan in the site enrollment plan. To date, we have visited over 20 sites who are now waiting for an accepted IND number. Once we have an accepted IND number, we can get the IRB and contracting process started with those sites. And so I do anticipate that we should be able to start the trial promptly after acceptance of the IND.

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Operator [4]

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Our next question comes from Ted Tenthoff with Piper Jaffray.

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Edward Andrew Tenthoff, Piper Jaffray Companies, Research Division - MD & Senior Research Analyst [5]

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Just following up on that, what are some of the outstanding issues with respect to the IND hold? And just to be a little bit clearer on timing, what are the next steps exactly? I want to make sure I understand that.

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Peter L. Hoang, Marker Therapeutics, Inc. - President, CEO & Director [6]

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Yes, absolutely, Ted. Why don't I turn the question over to Mythili Koneru, our Head of Medical Operations?

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Mythili Koneru, Marker Therapeutics, Inc. - SVP of Clinical Development [7]

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Regarding -- thank you, Peter. To address your -- the first part of your question, the FDA requested additional information specifically regarding certain quality and technical specifications for 2 reagents that were supplied by a third-party vendor that we use in our manufacturing process, but it's actually not present in the final product infused to patients. So because the FDA requires these data before planning -- allowing any of these planned studies to move forward under this IND, the IND was placed on clinical hold until our complete response to the technical questions is satisfactory to FDA.

So the idea that as we communicated in the press release, we've been working with the regulatory and quality groups at these respective manufacturers to address the FDA's request. And we've submitted a complete response to these issues that was raised by the FDA on October 28, 2019. So the FDA is going to respond within 30 days after receiving the complete responses and then indicate whether the hold is actually lifted. And if not, specifically the reasons why the clinical trial...

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Edward Andrew Tenthoff, Piper Jaffray Companies, Research Division - MD & Senior Research Analyst [8]

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That's really, really helpful because I think it puts into perspective just how maybe, hopefully, minor that says for the IND. So all the best in getting that up and going, and we're excited to hear more about the studies.

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Peter L. Hoang, Marker Therapeutics, Inc. - President, CEO & Director [9]

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Thanks, Ted. We really do see it as sort of not atypical from what we're seeing across the industry in biologics right now -- in cell therapy. So appreciate it.

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Operator [10]

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Our next question comes from Matt Biegler with Oppenheimer & Company.

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Matthew Cornell Biegler, Oppenheimer & Co. Inc., Research Division - Associate [11]

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Peter, what do you think really could be a worst-case scenario here with this IND delay? Do you think the FDA might require you to find a new vendor for those reagents that you mentioned? And if so, I mean how long would you estimate it would take to do equivalence testing?

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Peter L. Hoang, Marker Therapeutics, Inc. - President, CEO & Director [12]

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Yes. Matt, that's a good question. Let me once again refer to Mythili here. From what I can say, I think that the FDA acceptance at this point is really the gating item for us to start. Like I said, the site enrollment has gone, if anything, better than expected. And so I do think that we should be able to get pretty fast start as soon as we get acceptance.

My, do you have anything further to add?

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Mythili Koneru, Marker Therapeutics, Inc. - SVP of Clinical Development [13]

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Yes. I just would like to reiterate that we have been working very closely with these respective manufacturers and have submitted the response to the FDA's question. We do expect to initiate the Phase II clinical trial of our MultiTAA program for the treatment of post-transplant AML in 2020, and we feel confident about that.

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Matthew Cornell Biegler, Oppenheimer & Co. Inc., Research Division - Associate [14]

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Okay. That's helpful. And so the agency didn't have any concerns with the actual design of the AML trial, and you're still planning on moving forward with that same design, looking at both relapsed/refractory as well as maintenance patients, is that correct?

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The rest is here:
Edited Transcript of MRKR.OQ earnings conference call or presentation 12-Nov-19 10:00pm GMT - Yahoo Finance

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BrainStorm Announces Financial Results for the Third Quarter of 2019 and Provides a Corporate Update – GlobeNewswire

Tuesday, November 19th, 2019

Conference Call and Webcast Today at 8:00 a.m. Eastern Time

Highlights Include: ALS Phase 3 Clinical Trial Fully Enrolled, Data Safety Monitoring Board Recommends ALS Phase 3 Clinical Trial Continue, Appointment of CFO, Phase 2 in Progressive MS Continues to Enroll Patients

NEW YORK, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2019 and recent corporate updates.

On October 11, 2019 we reached a major corporate milestone by fully enrolling 200 patients in the Phase 3 clinical trial of NurOwn in ALS (Amyotrophic Lateral Sclerosis). Additionally, on October 28, we announced that we received notification from the NurOwn Data Safety Monitoring Board (DSMB) that after reviewing all of the safety data as of September 30, the study should continue without any changes in the protocol. The DSMB indicated they did not identify any significant safety concerns, stated Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. He added, Our Phase 2 trial of NurOwn in Progressive MS (Multiple Sclerosis) continues to enroll patients in several of the leading U.S. medical centers and we anticipate announcing additional investigational centers of excellence in the near future. The first eight (8) participants have been enrolled in the study.

Third Quarter 2019 and Recent Corporate Highlights:

Financial Results for the Three Months Ended September 30, 2019

For further details on BrainStorms financials, including financial results for the three months ended September 30, 2019, refer to Form 10-Q filed with the SEC on November 14th, 2019.

Conference Call and Webcast: Thursday, November 14, 2019 @ 8:00 a.m. Eastern Time

A webcast replay of the conference call will be available for 30 days on the Investors & Media page of BrainStorms website:

About NurOwnNurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com.

Safe-Harbor StatementStatements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIESINTERIM CONDENSED CONSOLIDATED BALANCE SHEETSU.S. dollars in thousands(Except share data)

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What to Know in Washington: Trump Ally in Impeachment Spotlight – Bloomberg Government

Tuesday, November 19th, 2019

After weeks of Republican complaints that the Democrats impeachment inquiry relied on secondhand information, the centerpiece of this weeks public hearings is testimony from a man with a direct line to President Donald Trump.

The political peril for Trump, who was dealt a series of setbacks last week, will be heightened as the House investigation accelerates with three days of public hearings starting tomorrow.

No witness is more central than Gordon Sondland, the U.S. ambassador to the European Union, a Trump donor and a confederate with Rudy Giuliani in back-channel diplomatic efforts for the president in Ukraine.

Sondland, scheduled to testify Wednesday, has already amended his previous closed-door testimony once because of discrepancies with other witnesses. And now there will be new questions for him to answer about Trumps pressure on the government in Kyiv to launch a probe entangling former Vice President Joe Biden and other political foes of the president.

David Holmes, a member of the embassy staff in Kyiv, came forward last week to tell impeachment investigators that following a phone conversation between Sondland and Trump, the EU envoy told him the president didnt give a s about Ukraine and that the president only cares about the big stuff that benefits him like the Biden investigation that Giuliani, Trumps personal lawyer, was promoting.

Testimony from Tuesday through Thursday will come from a disparate cast of witnesses, some of whom could prove pivotal to the impeachment inquiry, including officials from the State Department, the White House national security teams, and Vice President Mike Pences office. Read more from Ryan Teague Beckwith and Billy House.

Former Adviser SaysAid Was Tied to Probe: A former top White House adviser told House impeachment investigators Ukrainians were advised Sept. 1 that U.S. military aid was being withheld until their president announced an investigation of a company that had hired Bidens son, Hunter. Tim Morrison, a former senior director of European and Russian affairs at the National Security Council, said Sondland told him how he had informed a high-ranking Ukrainian official that release of $400 million in aid was being linked to the investigations, according to a transcript of his closed-door testimony released Saturday.

The House committee also released testimony from Jennifer Williams, an aide to Vice President Mike Pence, who said she found some of the discussion on the July 25 call between the two leaders to be unusual and inappropriate. Read more from Billy House.

Funding Deadline: Lawmakers are facing a deadline of Thursday to pass legislation to continue funding the government, before they depart for a recess through the week of Thanksgiving. House and Senate leadership have expressed optimism that both chambers will pass a measure ahead of the deadline, though no continuing resolution has been introduced as of this morning and the House schedule offered few details of the timing of a vote.

I hope we pass the CR, House Majority Leader Steny Hoyer (D-Md.) said on the floor Friday. I hope its as clean as it can be. The measure will contain some usual anomalies, noncontroversial changes in funding levels or legislative language, Hoyer said.

FDA Pick to Face Questions on Frankenfish, Stem Cells, Vaping: Trumps selection to be the next head of the FDA will face a barrage of questions this week about his views on vaping, oversight of stem-cell therapies and even Frankenfish. Stephen Hahn, chief medical executive of the prestigious MD Anderson Cancer Center at the University of Texas in Houston, will go before the Senate Health, Education, Labor and Pensions Committee Wednesday for his first public hearing since being nominated to become commissioner of the Food and Drug Administration. Alex Ruoff details what to expect.

Risch Warns Erdogan of Sanctions: Senate Foreign Relations Chairman Jim Risch (R-Idaho) warned that if Turkish President Recep Tayyip Erdogan persists in the deployment of a Russian air defense system, he will move ahead with a sanctions bill. It is his choice, and he knows the consequences, Risch said in a statement on Friday evening. Just a day earlier, Risch had said that the Senate should hold off on sanctions over Turkeys invasion of Syria if Erdogan agreed to give up the S-400 anti-aircraft missile system. Read more from John Harney.

Anti-Robocall Agreement Reached: House and Senate negotiators on Friday reached an agreement on bipartisan legislation to combat illegal robocalls, and anticipate a vote on the measure this year. The House and Senate passed separate legislation earlier this year with broad bipartisan support, and staff has been working since August to reach an agreement on provisions from the two anti-robocall bills. Read more from Rebecca Kern.

Democrats Subpoena EPA Over Formaldehyde Analysis: Rep. Eddie Bernice Johnson (D-Texas), chairwoman of the House Science, Space, and Technology Committee, sent two subpoenas to the EPA Friday over the agencys alleged refusal to provide answers about removing formaldehyde from its review program outlook. Johnson said in an accompanying letter to EPA Administrator Andrew Wheeler that the committee had suffered through eight months of delayed and insufficient responses. The subpoenas were sent to Wheeler and David Dunlap, deputy assistant administrator for the agencys Office of Research and Development. Read more from Stephen Lee.

Democrats Use Super-PACs to Combat Trump: Wealthy Democratic donors are pouring money into outside groups as part of their effort to defeat Trump in 2020, avoiding contributions to a party apparatus that lost in 2016 and to leading candidates who dont want their help. Outside groups aligned with Democrats have pledged to spend more than $300 million attacking Trump, far more than the $67 million raised by the Democratic National Committee. With little primary opposition, Trump and the Republican Party are already in general election mode, free to spend millions in states hell need to win a second term. The Democratic groups are being fueled by seven-figure checks necessary to advertise in battleground states, blunting Trumps big campaign cash advantage. Read more from Bill Allison.

Buttigieg Wants Public College Free for Some: Pete Buttigieg called for spending $120 billion on the Pell Grant program and making public colleges tuition-free for students eligible for those federal grants as part of his proposal released Monday to improve college affordability. Unlike some of his primary opponents, Buttigieg isnt calling for public colleges to be tuition-free for all students, or for total student-debt cancellation. Hes said families that make over a certain income threshold should pay at least some of the cost of their kids higher education. The plan released Monday focuses on helping lower- and middle-income families. Read more from Tyler Pager.

Louisiana Governors Re-election May Offer Lessons for 2020: John Bel Edwards proved its possible to buck Trumps popularity, winning a second term to remain the only Democratic governor in the Deep South. His victory will give political strategists important insights on what it takes to motivate turnout going into 2020, said University of Pennsylvania political science professor Daniel J. Hopkins. Voters may feel more empowered to back a moderate Democrat, said Hopkins, who explores the nationalization of state politics in his book, The Increasingly United States.

In Louisiana, Trump headlined three rallies to try to drive turnout for Republican Eddie Rispone. Edwards, meanwhile, ran on a record of demonstrated independence from his national party. Read more from Jennifer Kay.

North Carolina Lawmakers Back New Congressional Map: North Carolina lawmakers have approved new congressional boundaries to be used in the 2020 elections. The 13 current U.S. House district lines were redrawn after a state court decided Oct. 28 that the map in place since 2016 couldnt be used, pending further review. The North Carolina Superior Court for Wake County had found that plaintiffs were likely to prevail in a lawsuit claiming the boundaries were illegally drawn to maximize Republican advantage. Read more from Andrew M. Ballard.

Barr Blasts Democrats: Attorney General William Barr fired a broadside against critics of Trump and congressional Democrats in particular while defending the presidents actions. In a fiery speech before the conservative Federalist Society on Friday, Barr said Trumps opponents are using every tool they can to intentionally sabotage his administration. Immediately after President Trump won election, opponents inaugurated what they called the Resistance, Barr said. They essentially see themselves as engaged in a war, to cripple by any means necessary, a duly elected government. Read more from Chris Strohm.

Trump, Kim at Odds Ahead of Deadline: The bonhomie between Trump and North Korean leader Kim Jong Un is nearing a key deadline showing new signs of strain. Trump urged Kim over the weekend to act quickly to get a nuclear deal done, suggesting the two leaders could meet again soon. His comments came hours after North Korea ruled out nuclear talks without a policy change by the U.S. and reported on a military drill observed by Kim himself.

Veteran North Korea nuclear adviser Kim Kye Gwan told Trump that Pyongyang will no longer give him things to boast about, the states official KCNA news agency today quoted him as saying. He added North Korea is no longer interested in talks that the U.S. uses to buy time. Read more from Glen Carey and Jihye Lee.

Lawmaker Speaks Out Against U.S. Defense-Cost Hike: Rep. Grace Meng (D-N.Y.) said Trump is destabilizing the U.S.s relationship with South Korea by demanding the Asian nation pay about $5 billion, or five times the amount of its current one-year deal, to host U.S. troops, Jihye Lee reports. Meng tweeted a letter Friday asking Defense Secretary Mark Esper and Secretary of State Michael Pompeo to devise a better strategy that values the alliance, adding that such a hike would be extorting South Korea. Meng said such a request also puts U.S. national security and economic interests in jeopardy. She asked the U.S. officials to reconsider and engage in good faith negotiations.

Esper Has Great Faith in U.S. Military Justice System: Secretary Esper expressed his faith in the countrys military justice system, after Trump last week pardoned two soldiers convicted in Afghanistan killings, Glen Carey reports. Id say first of all that we have a very effective military justice system, Esper said during a press conference at the Asean Defense Ministers Meeting-Plus in the Thai capital of Bangkok yesterday. U.S. military personnel are trained from day one about the laws of armed conflict and how to conduct themselves during wartime, he said.

China, U.S. Trade Talks Continue: Top negotiators from China and the U.S. talked again this weekend, after signs of concessions from both sides on some of the outstanding issues. Chinas Vice Premier Liu He, the countrys key negotiator in the trade talks with the U.S., spoke with Treasury Secretary Steven Mnuchin and Trade Representative Robert Lighthizer by phone on Saturday morning Beijing time, according to the Chinese Commerce Ministry. They had constructive discussions about each sides core concerns in the phase-one deal, and agreed to stay in close communication, the statement said. The USTR confirmed the call took place. Read more.

Trump to Tour Apples Austin Plant: President Donald Trump is scheduled to tour an Apple manufacturing plant in Austin, Texas, on Wednesday, the White House said yesterday. The president plans to visit the plant along with Apple CEO Tim Cook, according to a tweet by spokesman Judd Deere. The Austin American-Statesman newspaper reported that Trump will travel with Treasury Secretary Steven Mnuchin and other administration officials.

The company announced in September that its new Mac Pro computer will be assembled in Texas after it received exclusions from the Trump administration from tariffs on certain parts imported from China. The visit also comes at a time the U.S. and China are close to finalizing the first phase of a highly-anticipated trade deal. Read more from Hailey Waller.

Facebook, Google Donate Heavily to Privacy Advocacy Groups: Few companies have more riding on proposed privacy legislation than Google and Facebook. To try to steer the bill their way, the giant advertising technology companies spend millions of dollars to lobby each year, a fact confirmed by government filings. Not so well-documented is spending to support highly influential think tanks and public interest groups that are helping shape the privacy debate, ostensibly as independent observers.

Bloomberg Law examined seven prominent nonprofit think tanks that work on privacy issues that received a total of $1.5 million over an 18-month period ending Dec. 31, 2018. The groups included such organizations as the Center for Democracy and Technology, the Future of Privacy Forum and the Brookings Institution. The actual total is undoubtedly much higherexact totals for contributions were difficult to pin down. Read more from Daniel R. Stoller.

Scalia Says Big Law is Unwilling to Defend Conservative Views: Major law firms are shying away from defending conservative viewpoints in court, a trend that should trouble the legal profession, Labor Secretary Eugene Scalia told a group of right-leaning lawyers at a Federalist Society event on Friday. It is appropriate, admirable, and necessary for lawyers to take on clients and advance positions that may offend some observers, Scalia said. But some of the countrys biggest law firms appear to be disinclined to protect free speech and free trade in ideas, he argued, calling that evidence of a broad trend of conservative political views being under attack. Read more from Jaclyn Diaz.

To contact the reporters on this story: Zachary Sherwood in Washington at zsherwood@bgov.com; Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Loren Duggan at lduggan@bgov.com

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Do transhumanists need their own bill of rights? – Quartz

Sunday, October 27th, 2019

In todays future-facing era, phenomena once relegated to the world of science fiction are starting to edge their way into reality.

We have scientists growing brains from stem cells in petri dishes; robots are being granted national citizenship; virtual intelligences experience and expressanger.

For the past 50 years, the microprocessorthe chip that processes information in a computerhas doubled in capacity at least everyyear to two years. Experts predict that machine intelligence will be smarter than humans by 2030.

So heres my question: When the machines weve created possesses an intelligence that equals ours, will they deserve our protection?

Will they desire it? Maybe even demand it?

This should be your question, too. Because in a little longer than a decades time, well need answers if want to avert moral and civil rights mishaps.

Futurists and technologists have been working to prepare the world for radical new sapient technologies and intelligences with publications such as the Cyborg Bill of Rights V1.0 which advocates equality for mutants.

Beyond the microprocessor, instrumental in catapulting machine intelligence to new levels through its ever-increasing speed for calculations, weve seen accelerating advances in genetic editing, stem-cell research, and 3D bioprinting, each which will help to create entities that have both consciousness and intelligence. This year 3D bioprinting has come so far that a team of Israeli scientists were able to successfully print part of a human heart.

Netflix released a popular four-part documentary series called Unnatural Selection on the topic.

Scientists are already wading into murky waters when it comes to the rights of these new intelligent organisms that we create. AtYale University brains from deceased pigs are being stimulated in a vat, which has prompted controversy in the animal rights world.

Do the brains of these animals, once dead, now represent live animals? And if so, do they receive the same legal rights that have informed laws that protect animals against harmful animal testing and animal cruelty?

As a result of these emerging ethical issues, were seeing more debates about new terms of futurist-oriented rights.

But the fact remains that there are few, if any, actual rules for most of our new scientific realities.

This is largely what inspired me to come up with theTranshumanist Bill of Rights, which Wiredpublished in full in 2018. The document recently underwent its third rendition via crowdsourcing.

When the machines weve created possesses an intelligence that equals ours, will they deserve our protection?

Like many of the cyborg bills that existthere are about half a dozen significant ones floating around the internetthis bill includes legal protections for thinking robots, gender explanations for virtual intelligences, laws for genetically engineered sapient creatures, defense of freedoms allowing biohackers to modify their bodies, and many other protections. It even includes policies to fight off environmental destruction and planetary existential threats such as asteroids, plagues, nuclear war, and global warming.

In 2015, Iwalked up to the US Capitol building holdinga single-page print out of the document I had written. The machine gun-toting police standing guard just feet away from me threatened arrest, but there was little need; the taped-on page quickly fell off the building, fluttered off the wall in the wind.

I wasnt arrested. The police and journalists surrounding me chuckled at the bungled ceremonial moment.

I recall that I couldnt help but smile myself at the idea of getting a futurist bill of rights to become a fixed part of US governing policy at the time.

But four years later, with machines showing ever increasing sophisticationhumans are even marrying robotsin some parts of the worlda bill of rights is not as wild as it once sounded. We could easily say the same for genetically-modified babies being born, which happened for the first time inChinalast year.

In my work, I meet with people around the world who are interested in answering not if we need a futurist bill of rights, but when we will need it, from Harvard Universitys Kennedy School of Government to theCato Institute to theWorld Economic Forumto European ministries.

If you look through the various cyborg-inspired bills of rights already out there, youll find that a major goal is to include cyborg and transhumanist rights in the UNs 1948Universal Declaration of Human Rights one day.

The ideas of personhood, a right to education, and freedom of speech were once considered unattainable in some countries. Now these basic human rights are common, and at least some of this change is due to the powerful legal influence of the UNs universal bill, often seen as a blueprint for governments and laws around the globe.

Interestingly, one of the challenges of getting a transhumanist bill of rights taken seriously comes from minorities groups, when its perceived that futurist rights will undermine movements of historically marginalized peoples. While plenty of transhumanists are members of the LGBTQ community, the community has been reluctant to wander intofuturist LGBTQissues, such as nongender roleplaying as different species in virtual environments.

LGBTQ friends of minewhile often sympathetic to transhumanist goalshave told me that they believe that after their historic quest for rights in America especially, they still need to focus on progress for their own movement and its goals. They perceive a futurist bill of rights as a distraction.

I respect and agree with this. Minorities in the US and around the world face social discrimination and violations of rights that warrant our attention. But it wont slow down the trajectory of radical technologies, which is spurring a growing futurist community to call for its own set of rights, rules, and protections.

I understand that at times it seems preposterous to believe the world will need to consider whether super intelligentrobots can vote, or whether human heads can betransplantedto waiting tech-engineered bodies, or if four years of college education canbe downloadedinto human brains.

But these realities are likely to occur long before the century is out.

If society doesnt accept that new sapient lifeformswhether its an autonomous digital avatar living in a supercomputer, or a biological creature with human-level intelligence that genetic editing createdalso need rights, or that new forms of engineered conscious intelligences will walk among humans on Earth as a result of scientific progress, society will undergo another wave of civil strife as we scramble to play catch-up to whats fair and moral.

At the very least, societies and governments need more comprehensive plans to formally deal with these new realities. That begins with a Congressional dialogue and forming preliminary legal documents outlining potential rights for the evolving future.

Ultimately, it comes down to how humans believe new intelligent life deserves to be treated.

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Do transhumanists need their own bill of rights? - Quartz

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Does Stem Cell Therapy Work For Back Pain? – Regenexx

Tuesday, October 8th, 2019

Does stem cell therapy for back pain actually work? If so, can stem cell therapy work for degenerative disc disease? What kinds work better than others? Is stem cell therapy covered by insurance? And does Stem Cell Therapy Work for Back Pain? Lets dig in.

Back in 2005, I was one of the first humans on earth to inject stem cells into a human disc. In the past almost two decades Ive published and learned much about what works and doesnt work. My goal here is to make sure that I transfer that wisdom to you to keep you from getting scammed.

Before we jump into stem cell therapy for back pain, its critical to review what the targets for the therapy would be. Meaning, what causes back pain? Lots of things:

Its critical when looking for the right stem cell therapy for back pain that you follow the Who, What, and Where method. If you dont, youre more likely than not to get scammed. So how does that work?

Who will perform the stem cell therapy for back pain is critical. Given that the stem cells need to be placed into specific spots that are causing pain and this requires advanced imaging guidance and training to do safely, getting this injection procedure done by a nurse or physicians assistant or even a non-specialist family physician just isnt a viable option. You need a spine specialist who can perform precise injections using an x-ray technology known as fluoroscopy.

What will be injected is also critical. As an example, a common message youll hear at seminars is that the clinic uses young and vibrant stem cells from amniotic fluid or umbilical cords! Theres just one problem with that message and its called reality. Meaning multiple studies have now shown that the products used by these clinics contain no live and viable stem cells, in fact, these preparations theyre using are all dead tissue (1-3). In fact, the only stem cell therapy out there right now that can be performed in the United States is Bone Marrow Concentrate (BMC) from the same patient, which contains many live and viable mesenchymal stem cells (4). BMC is obtained from a bone marrow aspirate at the back of the pelvis, centrifuged to concentrate the stem cell fraction, and then reinjected. Other possibilities include using cells that are cultured and grown to bigger numbers.

Where will the stem cells be reinjected? As discussed above, that could be many different areas from into the disc, around the nerves (epidural), into the facet joints, ligaments, muscles, etc Injecting stem cells into the wrong area will provide no results, so being able to diagnose where cells should go and then getting the cells to that specific area is critical.

Want to learn more about choosing a good stem cell clinic using this who, what, and where system? Click on the cover below to read that short mini-book:

Has medical research demonstrated that stem cell therapy for back pain is effective? Does Stem Cell Therapy Work for Back Pain? To answer that question, Ill include all regenerative medicine therapies, such as platelet-rich plasma (concentrated platelets from the patients own blood), bone marrow concentrate, and cultured stem cells (not available in the United States).

Theres pretty good research that platelet-rich plasma (PRP) can help various causes of back pain. For example, there is a high-level study showing that PRP can help painful low back discs (9). We published a research study on using a type of PRP called platelet lysate to help sciatica caused by bulged and herniated discs (10). In addition, PRP has been shown to help reduce the atrophy of low back stabilizing muscles as well (11). Finally, PRP has also been used to treat sacroiliac joint problems and was shown to better than steroid shots (12).

Next up is bone marrow concentrate. This has been used successfully to treat painful discs through injection (13). Practically, we have also used it to treat damaged facet joints, sacroiliac joint instability/pain, as well as degenerative disc disease. However, the sweet spot appears to be in treating painful disc tears that often reduce the ability of the patient to sit for any prolonged period of time.

While not legal in the United States, in other countries, the patients bone marrow stem cells can be cultured and grown to larger numbers. We have published on injecting these types of cells to treat bulging discs causing nerve root impingement (14, 15). There are a few others who have also published on a smaller number of patients.

Notice what you dont see in this section. There are no human studies on using amniotic or umbilical cord products in the spine. There is also nothing published in human patients where exosomes were used (a type of therapy beginning to be offered). Hence, if you go to a seminar that claims that there is copious research showing these things work well in real patients, then run.

One of the more common questions I get from patients on stem cell therapy for back pain is whether it can regrow a collapsed low back disc. The discs in the spine are cushions that sit between individual backbones (vertebrae). In DDD the disc collapses and this causes degenerative instability which can lead to facet joint arthritis, irritated nerves, and over the long run, stenosis.

So can stem cell therapy for back pain regrow a degenerated disc? There was a real promise that this would happen, as in animals like rabbits, this is easy to do (16). However, to date, in humans, reliable disc regeneration has remained elusive. Meaning that it is very unlikely that if you have a collapsed disc, injecting stem cells will grow you a new plump disc.

I created a little video on this topic, so please watch this for more information:

In addition, I wrote a whole book on this topic of stem cells for spine problems, click on the cover below to download a copy:

Regrettably, for most patients, stem cell therapy for back pain is not covered by major health insurers, Medicare, or Medicaid. However, Regenexx has had success in getting full coverage from various self-funded health plans. Click here to learn more about getting your employer to cover these procedures.

The upshot? Stem cell therapy for back pain is a promising alternative to surgery. However, making sure you actually get the real deal versus treatment with dead stem cells may take some homework!

___________________________________________

References:

(1) Berger D, Lyons N, Steinmetz, N. In Vitro Evaluation of Injectable, Placental Tissue-Derived Products for Interventional Orthopedics. Interventional Orthopedics Foundation Annual Meeting. Denver, 2015. https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf

(2) Becktell L, Matuska A, Hon S, Delco M, Cole B, Fortier L. Proteomic analysis and cell viability of nine amnion-derived biologics. Orthopedic Research Society Annual Meeting, New Orleans, 2018. https://app.box.com/s/vcx7uw17gupg9ki06i57lno1tbjmzwaf

(3) Panero, A, Hirahara, A., Andersen, W, Rothenberg J, Fierro, F. Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine, 2019 47(5), 12301235. https://doi.org/10.1177/0363546519829034

(4) Gianakos AL, Sun L, Patel JN, Adams DM, Liporace FA. Clinical application of concentrated bone marrow aspirate in orthopaedics: A systematic review.World J Orthop. 2017;8(6):491506. Published 2017 Jun 18. doi:10.5312/wjo.v8.i6.491

(5) Kalichman L, Carmeli E, Been E. The Association between Imaging Parameters of the Paraspinal Muscles, Spinal Degeneration, and Low Back Pain.Biomed Res Int. 2017;2017:2562957. doi:10.1155/2017/2562957

(6) Vleeming A, Schuenke MD, Masi AT, Carreiro JE, Danneels L, Willard FH. The sacroiliac joint: an overview of its anatomy, function and potential clinical implications.J Anat. 2012;221(6):537567. doi:10.1111/j.1469-7580.2012.01564.x

(7) Manchikanti L, Hirsch JA, Falco FJ, Boswell MV. Management of lumbar zygapophysial (facet) joint pain.World J Orthop. 2016;7(5):315337. Published 2016 May 18. doi:10.5312/wjo.v7.i5.315

(8) White, A. A., & Panjabi, M. M. (1978).Clinical biomechanics of the spine. Philadelphia: Lippincott.

(9) Monfett M, Harrison J, Boachie-Adjei K, Lutz G. Intradiscal platelet-rich plasma (PRP) injections for discogenic low back pain: an update. Int Orthop.2016 Jun;40(6):1321-8. doi: 10.1007/s00264-016-3178-3.

(10) Centeno C, Markle J, Dodson E, et al. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain.J Exp Orthop. 2017;4(1):38. Published 2017 Nov 25. doi:10.1186/s40634-017-0113-5

(11) Hussein M, Hussein T. Effect of autologous platelet leukocyte rich plasma injections on atrophied lumbar multifidus muscle in low back pain patients with monosegmental degenerative disc disease.SICOT J. 2016;2:12. Published 2016 Mar 22. doi:10.1051/sicotj/2016002

(12) Singla V, Batra YK, Bharti N, Goni VG, Marwaha N. Steroid vs. Platelet-Rich Plasma in Ultrasound-Guided Sacroiliac Joint Injection for Chronic Low Back Pain. Pain Pract. 2017 Jul;17(6):782-791. doi: 10.1111/papr.12526

(13) Pettine KA, Suzuki RK, Sand TT, Murphy MB. Autologous bone marrow concentrate intradiscal injection for the treatment of degenerative disc disease with three-year follow-up. Int Orthop. 2017 Oct;41(10):2097-2103. doi: 10.1007/s00264-017-3560-9.

(14) Centeno C, Markle J, Dodson E, et al. Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy.J Transl Med. 2017;15(1):197. Published 2017 Sep 22. doi:10.1186/s12967-017-1300-y

(15) Elabd C, Centeno CJ, Schultz JR, Lutz G, Ichim T, Silva FJ. Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study.J Transl Med. 2016;14(1):253. Published 2016 Sep 1. doi:10.1186/s12967-016-1015-5

(16) Sakai D1, Mochida J, Yamamoto Y, Nomura T, Okuma M, Nishimura K, Nakai T, Ando K, Hotta T. Transplantation of mesenchymal stem cells embedded in Atelocollagen gel to the intervertebral disc: a potential therapeutic model for disc degeneration. Biomaterials. 2003 Sep;24(20):3531-41. DOI: 10.1016/s0142-9612(03)00222-9

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The Ethical, Social & Legal Issues of Cloning Animals …

Tuesday, October 8th, 2019

Cloning suggests the possibility of growing or cultivating human beings in the future.

Cloning has been around since 1952 when Robert Briggs and Thomas King externally fertilized and developed a leopard frog using somatic cell nuclear transfer. Though scientists had discussed the need for communication about the ethical ramifications of cloning since as early as 1972, it was not until the successful cloning of a sheep named Dolly in 1997 that cloning came to the forefront of scientific and societal discussion. As a result of the continuity of fast-paced scientific discovery, the issues surrounding cloning of both animals and humans remain a hot topic, with people divided on both sides of the controversy.

From the production of vaccines to organ regrowth for transplantation, cloning from stem cells can improve people's health. In regards to the cloning of whole organisms, however, the benefits are largely found in increasing nutrition derived from food. In the United States, you frequently see whole organism cloning in the genetically modified foods you eat, which are FDA approved and not limited to plants but also to animals such as cloned pigs modified to be a source of omega-3 fatty acids that usually come from fish and certain seeds. Additionally, the replacement of dead or dying household pets and children with genetic disorders, termed ''reproductive cloning,'' has become a social argument in favor of cloning. In fact, in 2004 a company devoted solely to the cloning of household pets opened, and though it closed after only a short, two-year stint, some people continue to see this as a valuable route for cloning research.

From a religious standpoint, many argue that the act of cloning makes humans God, an equality not viewed as appropriate as humans lack omniscience. Morally, the arguments are more broad. The ethics of animal research come into play, where many, such as the moral philosopher Peter Singer, believe that all animals are created equal, suggesting animal testing in science should be completely eliminated. The possibilities of unforeseen health risks in cloned organisms and potential negative effects of decreased genetic variation on the human gene pool are seen as ethical causes for concern in addition to the mixed ethical and social consideration of increasing population sizes when worldwide resource availability is a problem.

The social issues of cloning tend to focus on human clones in terms of both availability of cloning technology and integration of clones into society. Reproductive cloning raises the question of cost and who should have access. However, the biggest social argument is that cloning negates a person's right to individuality and ignores the potential psychological effects of such a parentless and de-individualized identity.

Legally, funding has always been a concern for cloning research. Many believe the government and taxpayer money should not support research not agreed upon by a clear majority, and in this respect, the U.S. Congress has continued to prohibit use of taxpayer dollars for any research that may result in the death of human embryos. However, reproductive animal cloning continues not just in the U.S., but around the world. The biggest legal issues concerning animal clones are who should be responsible for and at what depth there should be oversight and accountability, as well as the legal right to patent live organisms.

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An Overview of Stem Cell Research | The Center for …

Saturday, October 5th, 2019

Post Date: 04/2005, Updated 08/2009Author: CBHD Research Staff

In November of 1998, scientists reported that they had successfully isolated and cultured human embryonic stem cellsa feat which had eluded researchers for almost two decades. This announcement kicked off an intense and unrelenting debate between those who approve of embryonic stem cell research and those who are opposed to it. Some of the most prominent advocates of the research are scientists and patients who believe that embryonic stem cell research will lead to the development of treatments and cures for some of humanitys most pernicious afflictions (such as Alzheimers disease, Parkinsons disease, heart disease, and diabetes). Among the most vocal opponents of the research are those who share the desire to heal, but who object to the pursuit of healing via unethical means. CBHDs view is that because human embryonic stem cell research necessitates the destruction of human embryos, such research is unethicalregardless of its alleged benefits. Ethical alternatives for achieving those benefits should be actively pursued, and have demonstrated a number of promising preclinical and clincial results without the ethical concers present with embryonic stem cells.

Human embryonic stem cells are the cells from which all 200+ kinds of tissue in the human body originate. Typically, they are derived from human embryosoften those from fertility clinics who are left over from assisted reproduction attempts (e.g., in vitro fertilization). When stem cells are obtained from living human embryos, the harvesting of such cells necessitates destruction of the embryos.

Adult stem cells (also referred to as non-embryonic stem cells) are present in adults, children, infants, placentas, umbilical cords, and cadavers. Obtaining stem cells from these sources does not result in certain harm to a human being.

Fetal stem cell research may ethically resemble either adult or embryonic stem cell research and must be evaluated accordingly. If fetal stem cells are obtained from miscarried or stillborn fetuses, or if it is possible to remove them from fetuses still alive in the womb without harming the fetuses, then no harm is done to the donor and such fetal stem cell research is ethical. However, if the abortion of fetuses is the means by which fetal stem cells are obtained, then an unethical means (the killing of human beings) is involved. Since umbilical cords are detached from infants at birth, umbilical cord blood is an ethical source of stem cells.

Yes. In contrast to research on embryonic stem cells, non-embryonic stem cell research has already resulted in numerous instances of actual clinical benefit to patients. For example, patients suffering from a whole host of afflictionsincluding (but not limited to) Parkinsons disease, autoimmune diseases, stroke, anemia, cancer, immunodeficiency, corneal damage, blood and liver diseases, heart attack, and diabeteshave experienced improved function following administration of therapies derived from adult or umbilical cord blood stem cells. The long-held belief that non-embryonic stem cells are less able to differentiate into multiple cell types or be sustained in the laboratory over an extended period of timerendering them less medically-promising than embryonic stem cellshas been repeatedly challenged by experimental results that have suggested otherwise. (For updates on experimental results, access http://www.stemcellresearch.org.)

Though embryonic stem cells have been purported as holding great medical promise, reports of actual clinical success have been few. Instead, scientists conducting research on embryonic stem cells have encountered significant obstaclesincluding tumor formation, unstable gene expression, and an inability to stimulate the cells to form the desired type of tissue. It may indeed be telling that some biotechnology companies have chosen not to invest financially in embryonic stem cell research and some scientists have elected to focus their research exclusively on non-embryonic stem cell research.

Another potential obstacle encountered by researchers engaging in embryonic stem cell research is the possibility that embryonic stem cells would not be immunologically compatible with patients and would therefore be rejected, much like a non-compatible kidney would be rejected. A proposed solution to this problem is to create an embryonic clone of a patient and subsequently destroy the clone in order to harvest his or her stem cells. Cloning for this purpose has been termed therapeutic cloningdespite the fact that the subject of the researchthe cloneis not healed but killed.

Underlying the passages of Scripture that refer to the unborn (Job 31:15; Ps. 139:13-16; Lk. 1:35-45) is the assumption that they are human beings who are created, known, and uniquely valued by God. Genesis 9:6 warns us against killing our fellow human beings, who are created in the very image of God (Gen. 1:26-27). Furthermore, human embryonic lifeas well as all of creationexists primarily for Gods own pleasure and purpose, not ours (Col. 1:16).

Many proponents of human embryonic stem cell research argue that it is actually wrong to protect the lives of a few unborn human beings if doing so will delay treatment for a much larger number of people who suffer from fatal or debilitating diseases. However, we are not free to pursue gain (financial, health-related, or otherwise) through immoral or unethical means such as the taking of innocent life (Deut. 27:25). The history of medical experimentation is filled with horrific examples of evil done in the name of science. We must not sacrifice one class of human beings (the embryonic) to benefit another (those suffering from serious illness). Scripture resoundingly rejects the temptation to do evil that good may result (Rom. 3:8).

No forms of stem cell research or cloning are prohibited by federal law, though some states have passed partial bans. Private funds can support any practice that is legal, whereas federal funds cannot be used for research on embryonic stem cell lines unless they meet the guidelines set forth by the National Institutes of Health in July 2009. For the latest developments you can stay informed via CBHD's newsblogwww.bioethics.com and thecoalition site http://www.stemcellresearch.org.

Editor's Note: This piece was originally published by Linda K. Bevington, MA, by CBHD in April 2005 under the title "Stem Cell Research and 'Therapeutic' Cloning: A Christian Analysis." The piece was subsequently revised and updated by CBHD research staff in August 2009.

Posted 4/2005, Updated 8/2009

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