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Stem Cell Banking Market is forecast to reach $6,956 million by 2023 | ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save – The Daily…

Friday, October 2nd, 2020

The global stem cell banking market was valued at $1,986 million in 2016, and is estimated to reach $6,956 million by 2023, registering a CAGR of 19.5% from 2017 to 2023. Stem cell banking is a process where the stem cell care isolated from different sources such as umbilical cord and bone marrow that is stored and preserved for future use. These cells can be cryo-frozen and stored for decades. Private and public banks are different types of banks available to store stem cells.

Top Companies Covered in this Report: Cord Blood Registry,ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save, New York Cord Blood Program, CordVida, Americord, CryoHoldco, Vita34

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Increase in R&D activities in regards with applications of stem cells and increase in prevalence of fatal chronic diseases majorly drive the growth of the global stem cell banking market. Moreover, the large number of births occurring globally and growth in GDP & disposable income help increase the number of stem cell units stored, which would help fuel the market growth. However, legal and ethical issues related to stem cell collections and high processing & storage cost are projected to hamper the market growth. The initiative taken by organizations and companies to spread awareness in regards with the benefits of stem cells and untapped market in the developing regions help to open new avenues for the growth of stem cell banking market in the near future.

The global stem cell banking market is segmented based on cell type, bank type, service type, utilization, and region. Based on cell type, the market is classified into umbilical cord stem cells, adult stem cells, and embryonic stem cells. Depending on bank type, it is bifurcated into public and private. By service type, it is categorized into collection & transportation, processing, analysis, and storage. By utilization, it is classified into used and unused. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Table Of Content

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW

CHAPTER 4: STEM CELL BANKING MARKET, BY CELL TYPE

CHAPTER 5: STEM CELL BANKING MARKET, BY BANK TYPE

CHAPTER 6: STEM CELL BANKING MARKET, BY SERVICE TYPE

CHAPTER 7: STEM CELL BANKING MARKET, BY UTILIZATION

CHAPTER 8: STEM CELL BANKING MARKET, BY REGION

CHAPTER 9: COMPANY PROFILES

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Stem Cell Banking Market is forecast to reach $6,956 million by 2023 | ViaCord,Cryo-Cell, China Cord Blood Corporation, Cryo-Save - The Daily...

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Those linked to stem cell board received more than $2.1 billion – Capitol Weekly

Wednesday, September 16th, 2020

Over the last 15 years, Californias stem cell agency has spent $2.7 billion on research ranging from arthritis and blindness to cancer and incontinence. The vast majority of the money has gone to enterprises that have ties to members of the agencys governing board.

All of which is legal. All of which is not likely to change.

Eight out of every ten dollars that agency has handed out have been collected by 25 institutions such as Stanford University, multiple campuses of the University of California and scientific research organizations. Their combined total exceeds $2.1 billion.

All 25 have links directly or indirectly to past or present members of the board of the agency, according to an analysis by the California Stem Cell Report, which has covered the agency since 2005.

They (the agencys directors) make proposals to themselves, essentially, regarding what should be funded. They cannot exert independent oversight, says Harold Shapiro, who led a 2012 study of the agency by the prestigious Institute of Medicine (IOM), which is now called the National Academy of Medicine. The study recommended a major restructuring of the agencys board to help deal with the problem.

The longstanding, conflict-of-interest issues are not addressed in Proposition 14 on the Nov. 3 ballot. The measure would give the agency, officially known as the California Institute for Regenerative Medicine (CIRM), $5.5 billion more and expand its scope of activities and research. The ballot measure is likely to increase the problems by increasing the size of the agencys governing board from 29 to 35.

Another ballot initiative, Proposition 71, created Californias stem cell program in 2004. Ever since, conflict of interest questions have dogged CIRM. Indeed, critics of the agency can today point to the top five recipients of CIRM largess as examples of conflict problems. Stanford University ranks as the No. 1 recipient with $388 million. UCLA is No. 2 with $307 million. It is followed by UC San Diego, $232 million; UC San Francisco, $199 million, and UC Davis, $143 million.

All have had a representative on the CIRM board since the inception of the program.

Editors note CIRMs totals may change slightly as the result of the agencys internal accounting procedures.

IOM and public confidence in CIRMThe IOM study, with its criticism of conflicts, was commissioned by CIRM at a cost of $700,000. Directors expected that it would provide a gold standard evaluation of the agency that would support a ballot measure for additional funding. The studys scope went well beyond conflicts of interest. In fact, it said it did not search for evidence of specific conflicts because the task was not part of the agreement with CIRM. The IOM did say that studies from psychology and behavioral economics show that conflict of interest leads to unconscious and unintentional self-serving bias and to a bias blind spot that prevents recognition of ones own bias. While all of the studys findings were consequential, the matter of conflicts attracted the most public attention.

Ties to stem cell board lucrative, said a headline in the Orange County Register shortly after the IOM report was released.

The agency has used more than half of its funding and one day will almost certainly want to ask taxpayers for more. It should remember that voters will look for evidence of public accountability as well as respected research, said the Los Angeles Times in an editorial in December 2012.

The IOM report itself said, Far too many board members represent organizations that receive CIRM funding or benefit from that funding. These competing personal and professional interests compromise the perceived independence of the ICOC (the CIRM governing board), introduce potential bias into the boards decision making, and threaten to undermine confidence in the board.

The IOM said the composition of the board makes it neither independent nor capable of oversight, although the board is legally dubbed the Citizens Independent Oversight Committee (ICOC).

Placing deans of medical schools and patient advocates on the board who are linked to specific diseases raises questions about whether decisions delegated to the boardparticularly decisions about the allocation of fundswill be made in the best interests of the public or will be unduly influenced by the special interests of board members and the institutions they represent. Such conflicts, real or perceived, are inevitable.

The situation involves more than legalisms. Properly understood, the IOM said, conflict of interest is not misconduct, but bias that skews the judgment of a board member in favor of interests that may be different from or narrower than the broader interests of the institution.

The IOM study additionally surveyed board members about conflicts of interest and reported, While a majority of respondents stated that personal interests did not play a role in their work on the ICOC, some responses were more equivocal. One respondent replied that it was hard to tell given that so many decisions take place off camera in secret meetings, while another acknowledged that ICOC members are human, and, of course, their decisions are influenced by personal beliefs and interests.

The inherent conflictsThe conflicts were built in by Proposition 71, which dictated the composition of CIRMs 29-member board. CIRMs general counsel, James Harrison, once described the situation as inherent conflicts of interest.

Under Proposition 71, representatives from virtually all the California institutions that stood to benefit were given seats at the table where spending plans are approved and awards handed out. Directors are not allowed to vote on specific awards to their institution. But they control the direction of the agency and what CIRM calls concept plans, including specific elements and budgets for the award rounds. Some of those rounds run into hundreds of millions of dollars.

One of the concept plans created a $47 million program to help California institutions recruit star scientists to the Golden State. Another plan created the $50 million Alpha Clinic Network at five academic centers all connected to board members.

Following the IOM report, the CIRM board did remove most institutional directors from meetings where awards are ratified. Jonathan Thomas, chair of the board, declared then that financial conflict issues were put to bed once and for all, a position that the agency holds today. In May 2019, Thomas told directors that several authoritative entities have studied CIRM and produced written reports that dealt with conflict matters.

Thomas said, Each had in it sort of quite vehement language about the conflict of interest issue, which has always been just perceived..With respect to any given funding award, theres never been an actual conflict.

During the 2019 meeting, the board did not discuss issues involving board action on concept plans. They continue today to modify and approve concept plans.

Beyond the CIRM boardConflicts of interest at CIRM go beyond the 29-member board. In 2014, the agency was shocked by a case involving a former president of the agency, Alan Trounson, and StemCells, Inc., a company that was awarded $40 million while he was serving as the top executive at CIRM. (The company later declined one of the awards.) Only seven days after his final day at CIRM, Trounson was named to the board of directors of StemCells, Inc.

He served on the companys board for about two years and received $443,500 in total compensation, including stock options, according to StemCells, Inc., documents filed with the Securities and Exchange Commission.

Following the announcement of the Trounson appointment, CIRM looked into some of Trounsons work at CIRM. In July of 2014, the agency said that its severely limited investigation found no evidence that its former president attempted to influence action on behalf of StemCells, Inc., during the previous month. The states political ethics agency, the Fair Political Practices Commission, said in a Feb. 6, 2015, letter to Trounson that there was insufficient evidence to demonstrate a legal violation.

Even before the agency was created, critics warned of conflict-of-interest problems. Writing in an opinion piece in October 2004 in the San Francisco Chronicle, David Winickoff, then a professor at UC Berkeley, said, Contrary to what its name suggests, the ICOC is neither independent of interest-group politics nor does it include any citizen members. Hard- driving university scientists, disease group advocates and private industry executives who will make up the ICOC all have vested interests in how the money is to be used.

A sampling of conflictsThe California Stem Cell Report, which calculated the percentage of awards linked to institutional directors, has chronicled the conflicts issues at CIRM over the past 15 years. In 2012, its analysis showed that 92 percent of awards had been collected by institutions tied to past and present directors. The figure dropped to 79 percent by this summer as the types of grantees have widened. Here is a sampling of conflict issues that have surfaced publicly over the years.

In 2007, violations involving five board members resulted in voiding applications from 10 researchers seeking $31 million. The applications included letters of support signed by deans of medical schools who also sat on the CIRM board of directors. Directors are barred from attempting to influence a decision regarding a grant. The agency blamed its employees for the problem.

In 2008, public complaints by one applicant from industry about conflicts of interest on the part of a reviewer were briefly aired at a public board meeting. The then chair of the CIRM board, Robert Klein, told the applicant the board needed instead to discuss naming CIRM-funded labs and then go to lunch. CIRM later refused to release the letter from the applicant detailing the problem.

In 2009, board member John Reed, then CEO of the Sanford-Burnham Institute, was warned by the states Fair Political Practices Commission about his violation of conflict of interest rules. Reed intervened with CIRM staff on behalf of a $638,000 grant to his organization. Reed took his action at the suggestion of then CIRM Chair Klein, an attorney who led the drafting of Proposition 71.

Also in 2009, then board member Ted Love, who had deep connections in the biomedical industry, served double duty for the agency. He was the interim chief scientific officer and helped to develop the agencys first, signature $225 million disease team round while he was still serving on the board. As chief scientific officer, Love would have had access to proprietary information and trade secrets in grant applications.

When questioned, CIRM said that Love would serve only as a part-time advisor to the agency president, not as chief scientific officer. Nonetheless, in 2012, the board adopted a resolution with high praise for Love and his performance specifically as the chief scientific officer.

Beginning in 2010, a stem cell firm, iPierian,Inc., whose major investors contributed nearly $6 million to the ballot measure that created the stem cell agency, received $3.9 million in awards from the agency. The contributions were 25 percent of the total in the campaign, which was headed by Bob Klein. (See here and see here.)

In 2011, the chairman of the CIRM grant review group resigned from his position as the result of another violation, which the agency felt necessary to report to the California legislature. John Sladek, former president of Cal Lutheran University in Los Angeles, co-authored scientific publications with a researcher who was listed as a consultant on a CIRM grant application.

In 2012, StemCells, Inc., was awarded $40 million by the CIRM board despite having one of its $20 million applications rejected twice by grant reviewers. The action came after the board was vigorously lobbied by Klein, who had left his post as chair the previous year. Klein, who ran the Proposition 71 campaign, had campaign connections to researcher Irv Weissman of Stanford, who founded StemCells, Inc., and was on its board. Weissman was featured in a TV campaign ad for Proposition 71 and helped to raise millions for the 2004 ballot campaign.

The StemCells, Inc., awards were the first time that CIRM had approved that much money for one company, and the first time Klein lobbied his former board.

In 2012, an incident surfaced that illustrated how non-profit, disease-oriented organizations sometimes expect increased funding as the result of the appointment of sympathetic individuals to the board. That occurred when Diane Winokur was appointed to the board as a patient advocate. The chief scientist for The ALS Association, said Winokur will be a tremendous asset in moving the ALS research field forward through CIRM funding.

The IOM study identified as a problem the personal conflicts of interest involving the 10 patient advocates on the board. It said, (P)ersonal conflicts of interest arising from ones own or a family members affliction with a particular disease or advocacy on behalf of a particular disease also can create bias for board members.

In 2013, internationally renowned scientist Lee Hood, winner of a National Medal of Science, violated the conflict of interest rules of the California stem cell agency when he was involved in reviewing applications in a $40 million round to create genomics centers in California. The conflict involved connections between Hood, Weissman and Trounson. It was not discovered by the agency during the closed-door review and was raised by another reviewer at the end of the review. The review had to be redone later in the year.

Hood never commented publicly, but CIRM said he acknowledged the conflict.

In January 2014, the genomics round surfaced again. The applications were by then before the CIRM board for public ratification of reviewers decisions. The reviewers actions are taken behind closed doors with no public disclosure of reviewers personal, professional or economic conflicts.

The genomics round riled some researchers who complained publicly in letters to the agencys board about unfairness, apparent preferential treatment and manipulation of scores.

Only seven of the 29 members of the 29-member board could vote on the applications. Conflicts of interest and CIRM rules barred the rest from voting. The final vote on the award was 6-1 for a group led by Stanford. Two years earlier, however, when the concept plan was approved by the CIRM board, no directors were disqualified, even though some of their institutions were likely to benefit. The plan was approved on a show of hands. The transcript of the meeting does not indicate any negative votes or absentions.

The hidden review processUnder CIRMs rules, the scientists who review the applications must come from out-of-state. They do not have to disclose publicly their economic, personal or professional conflicts despite the fact that they make the de facto decisions on the applications. The board rubber stamps nearly all of the reviewers actions to approve funding. A CIRM examination of the practice in 2013 showed that 98 percent of reviewers decisions were ratified by the board. Since then, the agency has not produced a similar report. Occasionally, however, the board will approve an application that was not recommended for funding.

The CIRM governing board has resisted requiring public disclosure of the interests of reviewers. The subject has come up several times, but board members have been concerned about losing reviewers who would not be pleased about disclosing their financial and other interests.

Nonetheless, public disclosure of economic interests among researchers is routine in scientific research articles. Many universities, including Stanford, also require public disclosure of financial interests of their researchers.

At the time of Hood-Weissman-Trounson flap, Stanfords policy said, No matter what the circumstances if an independent observer might reasonably question whether the individuals professional actions or decisions are determined by considerations of personal financial gain, the relationship should be disclosed to the public during presentations, in publications, teaching or other public venues.

Proposition 71 placed the legal authority for grant approvals in the hands of the CIRM board. Traditionally in the world of science, other scientists ( peer reviewers), however, are deemed to be the most capable of making the scientific decisions about grant applications. The traditional practice calls for the reviewers to be anonymous and meet in private, which is also CIRMs practice.

If the CIRM board concedes the decisions to the grant reviewers, state law is likely to require public disclosure of their financial interests, a move that the board has opposed for years. Former CIRM Chairman Klein repeatedly advised the board during its public grant approval processes that reviewers actions were only recommendations, and that the board was actually making the decisions.

Proposition 14 implicitly recognizes, however, that a problem exists with directors approving concept plans for awards that could benefit their institutions.

To ease that problem legally, Klein inserted language in the new proposition that excludes adoption of strategic plans, concept plans and research budgets from being considered as matters involving conflicts of interest.

The measure does nothing to deal with matters involving the de facto, closed-door approval of awards by researchers who are unknown to the public and who do not have to publicly disclose their interests.

At the time the IOM report was released nearly eight years ago, some board members complained that its recommendations were unrealistic because of the likely, lengthy difficulties of altering a state law that had been created by the initiative. But since then, directors have not asked state lawmakers to change the structure of the board or to comply with the other $700,000 worth of IOM recommendations.

CIRM directors, however, missed an opportunity last year to seek conflict-easing changes through the $5.5 billion stem cell measure now on the ballot, Proposition 14.

Some board members have said they discussed the initiative privately with Bob Klein, who crafted the proposal last year.

Revision of CIRMs conflict rules was discussed at a board meeting in May 2019. Several board members expressed concerns about the loss of valuable insights from board members who cannot vote on applications. Some also expressed concerns about whether loosening the rules would damage the possibility of voter approval of a ballot measure to refinance the agency. Several, including CIRM Chair Thomas, also said theres never been a conflict involving a funding award and a board member. No action involving conflicts was taken at the meeting.Editors Note: DavidJensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report. He has published thousands of items on California stem cell matters in the past 11 years. This story was an excerpt from his upcoming book, Californias Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures, which s available for pre-order on Amazon.

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Those linked to stem cell board received more than $2.1 billion - Capitol Weekly

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Patenting Stem Cell Inventions in India- What to Expect? – Lexology

Sunday, September 13th, 2020

Stem cells offer hope as a promising treatment option for various diseases and are the future of medicine. Embryonic stem cells, have been at the heart of many debates globally, in view of the embryonic destruction or manipulation that their generation may require. Converging between research and law, patent law and policy grant yet throw their own challenges to obtaining exclusivity.

In India, in addition to satisfying the criteria of novelty and inventive step, inventions need to fall outside the realm of Section 3 of the Patents Act, to be patentable. Presenting an additional bar to patentability, Section 3 enlists inventions which are not patentable. Owing to this section it is oftentimes the case that the claim scope granted in India is quite different from that granted in other jurisdictions.

Public order and morality

Over the years, the Indian Patent Offices perspective on the issue of patentability of inventions involving embryonic stem cells, appears to have changed. This change in stance is apparent from the changes in the Manual of Patent Office Practice and Procedure. The 2005 draft of said guidelines treated the use of human or animal embryos for any purpose against public order and morality and prohibited the same from patentability. This restriction however, was removed from the subsequent draft of the guidelines and has not reappeared ever since.

Inspite of this change in the guidelines, the Patent Office till date raises the public order and morality objection under section 3(b) of the Patents Act, on stem cell related inventions (both methods and stem cell products). The concern most frequently expressed is the possibility of destruction of human embryos. The prosecution history of several cases shows that an objection on public order and morality has been raised even if the claims do not call out embryonic stem cells but the specification mentions the possibility of use of embryonic stem cells. The objection is frequently overcome by excluding any reference to embryonic stem cells from the claims and by disclaiming the use of embryonic stem cells in the operation of the invention.

However, the approach of treating stem cell research against public order and morality appears to be in contrast to public policy in India. The National Guidelines for Stem Cell Research (published by ICMR and DBT under the Ministry of Science and Technology) prescribe conditions subject to which research on stem cells should be conducted. The conditions include verification that the blastocysts used are spare embryos. The guidelines also permit establishment of new human embryonic stem cell lines from spare embryos subject to the approval of certain committees. Clearly, these government guidelines permit safe and responsible stem cell research, including research on embryonic stem cells.

Moreover, it is a well-known fact that not every invention involving embryonic stem cells would necessitate destruction of human embryos and a lot of research is based on embryonic stem cell lines. Therefore, the indiscriminate imposition of objections under Section 3(b) requires change.

Parts of Plants or Animals and Products of Nature

While claims relating to methods of isolation and propagation of stem cells are frequently granted, the Indian Patent Office appears to have never granted even a single application with claims directed to stem cells per se.

This brings us to another common objection frequently encountered in stem cell applications, namely, Section 3(j) which prohibits from patentability plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. Another commonly encountered objection is of Section 3(c) which bars the patentability of any living thing or non-living substance occurring in nature.

There is no judicial precedent that could throw light on what exactly constitutes parts of plants and animals under Section 3(j). The Patent Office considers any cell or tissue derived from plants or animals as parts of plants or animals leading to refusal of cell claims under this ground. Claims related to compositions comprising stem cells are also frequently refused as the compositions are treated as indirectly claiming stem cells. There have been some exceptions though, such as patent number 333231, where a composition comprising stem cells was granted.

A moot issue here is whether cells are actually parts of animals/plants or whether they can be treated as microorganisms. While the Patents Act permits the patentability of microorganisms (that do not occur in nature), the term microorganism has not been defined in either the Act or the manuals that the Patent Office has issued so far. In fact, even the TRIPS agreement which mandates member states to grant patents in relation to microorganisms does not define the term. The European Patent Office recognizes all generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory. (T 0356/93) as microorganisms.

Since the Patents Act does not limit the scope of the term microorganism and if one were to accept the literary or dictionary meaning of the term microorganism, it would appear that the Patents Act does not prohibit from the scope of patentability cells, which are not visible to the naked eye or which are so small that they require a microscope for viewing.

Moreover, stem cells like induced pluripotent stem cell and human parthenogenetic stem cells, which are somatic cells or oocytes that have been induced to develop the characteristics of unrestrained propagation and ability to develop into any cell type, are markedly distinct from the parent cell from which they are derived and are new cell types altogether. Such cells are indeed creations of man and cannot qualify as an animal part. They are also not living substances that occur in nature and being purely man made fall outside the prohibitory restraint of Section 3(c).

In the absence of judicial precedents and well defined guidelines, the law in India in relation to patentability of stem cell research is at a nascent stage. The Indian Patent Office has been following an unwritten code in the examination of these applications but the approach currently adopted is debatable. It is important to offer robust patent protection to encourage innovation in all fields. While there has been some change in the Patent Offices approach to patentability of stem cells and claims related to methods of producing, culturing and isolation of stem cells, culture media for stem cells, etc., are commonly granted, there is still a lot that can be patented but is currently not. Hopefully, India will see some judicial precedents in the future that will clarify the patentability issues that this field is struggling with.

This article was first published by Legal Era

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Patenting Stem Cell Inventions in India- What to Expect? - Lexology

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Global Stem Cell Banking Market Is Projected To Witness Vigorous Expansion By 2026 – Kewaskum Statesman News Journal

Sunday, September 13th, 2020

DBMR has added a new report titled Global Stem Cell Banking Market with data Tables for historical and forecast years represented with Chats & Graphs spread through Pages with easy to understand detailed analysis. this report provides exact information about market trends, industrial changes, and consumer behaviour etc. The report assists in outlining brand awareness, market landscape, possible future issues, industry trends and customer behaviour about industry which eventually leads to advanced business strategies. Being a verified and reliable source of information, this market research report offers a telescopic view of the existing market trends, emerging products, situations and opportunities that drives the business in the right direction of success. The report has been framed with the proper use of tools like SWOT analysis and Porters Five Forces analysis methods.

Global stem cell banking market is set to witness a substantial CAGR of 11.03% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. The increased market growth can be identified by the increasing procedures of hematopoietic stem cell transplantation (HSCT), emerging technologies for stem cell processing, storage and preservation. Increasing birth rates, awareness of stem cell therapies and higher treatment done viva stem cell technology.

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Competitive Analysis:

Global stem cell banking market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of inflammatory disease drug delivery market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key Market Competitors:

Few of the major competitors currently working in global inflammatory disease drug delivery market are: NSPERITE N.V, Caladrius, ViaCord, CBR Systems, Inc, SMART CELLS PLUS, LifeCell International, Global Cord Blood Corporation, Cryo-Cell International, Inc., StemCyte India Therapeutics Pvt. Ltd, Cordvida, ViaCord, Cryoviva India, Vita34 AG, CryoHoldco, PromoCell GmbH, Celgene Corporation, BIOTIME, Inc., BrainStorm Cell Therapeutics and others

Market Definition:Global Stem Cell Banking Market

Stem cells are cells which have self-renewing abilities and segregation into numerous cell lineages. Stem cells are found in all human beings from an early stage to the end stage. The stem cell banking process includes the storage of stem cells from different sources and they are being used for research and clinical purposes. The goal of stem cell banking is that if any persons tissue is badly damaged the stem cell therapy is the cure for that. Skin transplants, brain cell transplantations are some of the treatments which are cured by stem cell technique.

Cord Stem Cell Banking MarketDevelopment and Acquisitions in 2019

In September 2019, a notable acquisition was witnessed between CBR and Natera. This merger will develop the new chances of growth in the cord stem blood banking by empowering the Nateras Evercord branch for storing and preserving cord blood. The advancement will focus upon research and development of the therapeutic outcomes, biogenetics experiment, and their commercialization among the global pharma and health sector.

Cord Stem Cell Banking MarketScope

Cord Stem Cell Banking Marketis segmented on the basis of countries into U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

All country based analysis of the cord stem cell banking marketis further analyzed based on maximum granularity into further segmentation. On the basis of storage type, the market is segmented into private banking, public banking. On the basis of product type, the market is bifurcated into cord blood, cord blood & cord tissue. On the basis of services type, the market is segmented into collection & transportation, processing, analysis, storage. On the basis of source, market is bifurcated into umbilical cord blood, bone marrow, peripheral blood stem, menstrual blood. On the basis of indication, the market is fragmented into cerebral palsy, thalassemia, leukemia, diabetes, autism.

Cord stem cell trading is nothing but the banking of the vinculum plasma cell enclosed in the placenta and umbilical muscle of an infant. This ligament plasma comprises the stem blocks which can be employed in the forthcoming time to tackle illnesses such as autoimmune diseases, leukemia, inherited metabolic disorders, and thalassemia and many others.

Market Drivers

Increasing rate of diseases such as cancers, skin diseases and othersPublic awareness associated to the therapeutic prospective of stem cellsGrowing number of hematopoietic stem cell transplantations (HSCTs)Increasing birth rate worldwide

Market Restraint

High operating cost for the therapy is one reason which hinders the marketIntense competition among the stem cell companiesSometimes the changes are made from government such as legal regulations

Key Pointers Covered in the Cord Stem CellBanking MarketIndustry Trends and Forecast to 2026

Market SizeMarket New Sales VolumesMarket Replacement Sales VolumesMarket Installed BaseMarket By BrandsMarket Procedure VolumesMarket Product Price AnalysisMarket Healthcare OutcomesMarket Cost of Care AnalysisMarket Regulatory Framework and ChangesMarket Prices and Reimbursement AnalysisMarket Shares in Different RegionsRecent Developments for Market CompetitorsMarket Upcoming ApplicationsMarket Innovators Study

Key Developments in the Market:

In August, 2019, Bayer bought BlueRock for USD 600 million to become the leader in stem cell therapies. Bayer is paying USD 600 million for getting full control of cell therapy developer BlueRock Therapeutics, promising new medical area to revive its drug development pipeline and evolving engineered cell therapies in the fields of immunology, cardiology and neurology, using a registered induced pluripotent stem cell (iPSC) platform.In August 2018, LifeCell acquired Fetomed Laboratories, a provider of clinical diagnostics services. The acquisition is for enhancement in mother & baby diagnostic services that strongly complements stem cell banking business. This acquisition was funded by the internal accruals which is aimed to be the Indias largest mother & baby preventive healthcare organization.

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Research objectives

To perceive the most influencing pivoting and hindering forces in Cord Stem Cell Banking Market and its footprint in the international market.Learn about the market policies that are being endorsed by ruling respective organizations.To gain a perceptive survey of the market and have an extensive interpretation of the Cord Stem Cell Banking Market and its materialistic landscape.To understand the structure of Cord Stem Cell Banking Market by identifying its various sub segments.Focuses on the key global Cord Stem Cell Banking Market players, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).To project the consumption of Cord Stem Cell Banking Market submarkets, with respect to key regions (along with their respective key countries).To strategically profile the key players and comprehensively analyze their growth strategiesTo analyze the Cord Stem Cell Banking Market with respect to individual growth trends, future prospects, and their contribution to the total market.

Customization of the Report:

All segmentation provided above in this report is represented at country levelAll products covered in the market, product volume and average selling prices will be included as customizable options which may incur no or minimal additional cost (depends on customization)

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Global Stem Cell Banking Market Is Projected To Witness Vigorous Expansion By 2026 - Kewaskum Statesman News Journal

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How Close Are We To Making Babies from Bone Marrow? – Discover Magazine

Wednesday, August 12th, 2020

In 2007, a group of researchers reported a startling discovery: They had created sperm-like cells out of stem cells taken from the bone marrow of human men. Two years later, however, the study was retracted due to charges of plagiarism. Thirteen years later, the ability to create functional human sperm out of stem cells remains elusive.

Scientists have been trying to figure out how to create functioning human gametes eggs and sperm from stem cells for 20 or 30 years, says Vittorio Sebastiano, a stem cell biologist at Stanford University whose research focuses on reproductive biology. Doing so would help people struggling with infertility have children and help scientists unlock the secrets of human development. Since 2007, scientists have made considerable progress on this front, creating healthy mouse pups from stem cell-generated gametes and even immature human egg cells. But there is still a long road ahead before scientists will be able to convert skin or bone marrow into babies.

We are trying to really find ways to efficiently, robustly generate germ cells that can be, in the short term, used to understand the biology of these concepts, but in the long term [used to be] able to restore fertility, says Sebastiano.

When the first baby conceived via in vitro fertilization (IVF) was born in 1978, it was a major step forward for reproductive science and a precursor to the stem cell research conducted by Sebastiano and others today, he says. But IVF is not an option for every individual or couple trying to have a biological child, including those who are born without gametes or who receive aggressive cancer treatments at a young age. This scientific technique would offer these individuals a new shot at reproduction.

The next major step came in the 2000s, with the creation of induced pluripotent stem cells (iPSCs). These cells are taken from blood or skin cells and reprogrammed to behave like embryonic cells, which have the ability to develop into any type of cell in the body. Since then, researchers have been trying to figure out how to turn these embryonic-like cells into functional sperm and eggs.

A colony of induced pluripotent stem cells used to treat the rare genetic disorder Fanconi anemia. (Credit: Juan Carlos Izpisua Belmonte, Salk Institute for Biological Studies)

Part of what has made this work so challenging is that scientists havent been able to fully grasp what happens in a human embryo during normal development, says Sebastiano. Scientists understand this process in mice because the rodents are easy to study in the lab. But ethical restrictions and technical factors (like having access to the embryos at just the right point in time) make this phenomenon hard to study in people, he says.

Despite the roadblocks, scientists have made significant progress in the last 10 years. In 2012, a group of researchers in Japan created fertile mouse eggs from iPSCs and used those eggs to breed healthy mouse pups. In [the] mouse, the whole circle has already been completed, says Sebastiano. Now it has been shown by a couple of groups in the UK and in Japan that you can generate embryonic-like cells from mice and then you can actually push these cells to become eggs or sperm, fully functional.

In 2018, the same group of Japanese scientists made another major breakthrough. Using human blood cells and the pluripotent stem cell technique, they managed to produce immature human eggs.

Similar efforts to create sperm are not as far along, says Sebastiano. Several efforts over the years have purported to create sperm-like cells, including the 2007 blood marrow study. A much-heralded study published in 2014 also made major news, but Sebastiano says the development of the cells in that study didnt go far beyond the earliest stages of differentiation.

But, we are actively working on it, says Sebastiano. Probably in the next few years we will be able to generate fully functional sperm and fully functional oocytes. Then, the question will be how do scientists test the quality of these gametes, he says.

The only way to fully assess the quality and functionality of a sperm or egg is to use it to, well, try to fertilize another gamete and produce a baby. Thats why this work has to be approached with the utmost care, says Sebastiano. He hypothesizes that once scientists have developed techniques that they think produce mature human oocytes and sperm, the next step will be testing these techniques in primates. That way, researchers can follow the entire life of individual animals produced from this technique to see if any unexpected problems develop, he says.

Sebastiano has no doubt that one day, these stem cells could help individuals struggling with infertility to produce healthy children. This, along with a fascination with biological development, is what drives Sebastianos work. There are also, of course, significant ethical considerations that have to be carefully considered. This technique has the potential to affect human life on a generational level, he notes. And many people also raise concerns about other future consequences, like the ability to create designer babies or produce offspring from hairs stolen from unsuspecting celebrities. Bioethics experts have written about the need to start working through the medical and legal issues around this technique now, before it is viable.

There is a need actually to develop this, but since we are really dealing with a very unique cell type we need to be cautious, says Sebastiano.

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How Close Are We To Making Babies from Bone Marrow? - Discover Magazine

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India could bleed itself dry amidst covid-19 crisis owing to blood shortage – ETHealthworld.com

Sunday, July 12th, 2020

By Sh. Heera Lal

Indias blood shortage crisis is no alien to headlines. Now with a corona virus fear, blood banks in the country are going to face even tougher times ahead. Despite the massive burden of trauma and surgeries in the current situation, several hospitals in almost all states and union territories have been struggling to meet the daily requirements of blood in the past few weeks.

This disruption has impacted availability of blood for emergency surgeries, postpartum hemorrhage cases, thalassemia, sickle-cell disease, and cancer patients.

In India, blood donations have dramatically reduced due to the implementation of social distancing, cancellation of various blood drives and low donor turnout due to fears associated with catching infection from public places such as hospitals and blood banks.

The government needs to build more awareness on the compliance of safety protocols being followed by all blood banks and collection centres to instill confidence in public on voluntary blood donation in these uncertain times. In addition, support needs to be extended for easy as well as safe movement of donors and supply chain of critical materials and equipment used in blood and component collection.

The National Blood Transfusion Councils (NBTC) interim guidelines issued on 25 March 2020, emphasizes on continuity of supply of safe blood and recommends resuming both outdoor and in-house donation, in compliance with social distancing standards, biomedical-waste disposal rules and infection control guidelines. Guidelines state that people are at no risk of developing COVID-19 through the blood transfusion or via a blood donation procedure.

The lockdowns this year have restricted movement of people, so regular donors living far from a hospital or blood bank are unable to donate and finding new donors in nearby areas has become a huge challenge. All though people are afraid of attending camps and blood centers due to COVID-19, even then many donors are coming forward to save the life of those who need blood every month to survive.

Need of blood has also raised and this is a tough time when we have to weigh between the need of blood and fear of CORONA. Public is learning to live with CORONA, taking precautions, should also start voluntary donation as this is the need of time. This will require strong IEC.

Presently, Indias blood transfusion system (BTS) is extremely uneven, with almost no interlinkages. In absence of interaction and connectivity between blood banks, there is ineffective supervision of demand as well as supply in terms of accessibility and value of blood. Most of these issues in Indian blood system preexist due to low significance given to blood in our healthcare system, absence of a regulatory structure and insufficient financing in the BTS related infrastructure, although we already have a National Blood Policy of 2002, a devoted national blood legislation, which is completely absent.

Availability, Affordability, and Safety are the pillars that we need to make Indias blood system effective. In order to address these pillars and as suggested by World Health Organization (WHO), it is imperative for all actions related to blood collection, testing, processing, storage and distribution to be synchronized at a national level.

Indias massive trauma and surgical burden, high occurrence of blood disorders and communicable diseases linked with excessive Postpartum Hemorrhage (PPH) related deaths, imply that a well-operating blood system is the need of the hour and should be a top priority of our healthcare policy.

The timely availability of safe and quality blood is often a decisive factor in saving human life. An insufficient or unsafe blood supply for transfusion has a negative impact on the effectiveness of key health services and programs to provide appropriate patient care in numerous acute and chronic conditions.

In spite of the fact that Dos and Donts needed are sent to blood banks and donor organizers to make sure that donors and staff remain safe, due to fear of corona virus, people are not coming to blood banks or holding camps to donate blood.

Also due to restrictions of movement through the government besides the donors even the staff finds it difficult to reach the workplace. There is a need to provide special transport for donors and staff. The supplies of consumables and reagents required for collection and testing of blood are likely to face shortages if transport is not easily available.

The value of blood in any healthcare system cannot be weakened. To preserve India from the worldwide surgery blood drought, it is imperative for blood sufficiency, safety, and sustainability to become sacrosanct in Indias healthcare system.

The author is Additional Mission Director at National Health Mission, Uttar Pradesh.

DISCLAIMER: The views expressed are solely of the author and ETHealthworld.com does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person/organisation directly or indirectly.

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Court rules controversial stem cell research is legal

Friday, July 10th, 2020

The federal government may continue to pay for controversial human embryonic stem cell research, a federal appeals court ruled Friday.

The three-judge panel says the government has correctly interpreted a law that bans the use of federal funds to destroy human embryos for research. The ruling is unlikely to put the issue to rest and one of the judges pleaded for Congress to make clear what the government should and should not be able to do.

The hard-to-understand case pits science against mostly religious arguments against using embryos in medical research. It's even more confusing because there are so many differenlt types of cells called stem cells.

Dr. James Sherley of Boston Biomedical Research Institute and Theresa Deisher of AVM Biotechnology in Seattle, who both do research using adult stem cells and oppose the use of human embryonic stem cells, sued in 2009. They said federal guidelines violate the law and would harm their work by increasing competition for limited federal funding.

Its been back and forth in the federal courts since then, and Sherley has vowed to take the case all the way to the Supreme Court.

The embryonic stem cells at issue are the bodys master cells. Found in days-old embryos, they are the source of all the cells and tissues in the body blood, brain, bone and muscle. Researchers are studying them to investigate how disease develops and are using some as transplants to treat diseases from Parkinsons to cancer. They are being tested in people to repair spinal cord injuries and as a possible cure for some forms of blindness.

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Opponents of the research say its unacceptable to destroy a human embryo to get the cells. The 1996 Dickey-Wicker amendment, added by Congress to budget language every year, forbids the use offederal funds in research that destroys embryos.

When he was president, George W. Bush decided that the ban extended to human embryonic stem-cell research and greatly limited the federal program.

As one of his first acts after he entered office, President Barack Obama issued an executive order reversing this and encouraging the National Institutes of Health to pay for embryonic stem-cell research, so long as federal money wasnt used to directly make the stem cells. To get the cells, someone in a private lab using private money has to take apart the embryos usually left over from fertility clinics and destined for the trash can. Federal funds may be used to work with the cells that private labs make available.

On Friday, Judge Janice Rogers Brown, Judge David Bryan Sentelle, and Karen LeCraft Henderson of the U.S. Court of Appeals in Washington upheld an earlier court ruling throwing out the case. The law, they said permits federal funding of research projects that utilize already-derived embryonic stem cellswhich are not themselves embryosbecause no human embryo or embryos are destroyed in such projects.

As we have held before, the NIH interpretation of the statutes actual language is reasonable, they added.

"NIH will continue to move forward, conducting and funding research in this very promising area of science. The ruling affirms our commitment to the patients afflicted by diseases that may one day be treatable using the results of this research," NIH director Dr. Francis Collins said in a statement.

But Judge Brown wasnt entirely happy and asked Congress to please clear up the unclear wording of the Dickey-Wicker amendment and saying there are aspects of this case that should trouble the heart.

Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate, she wrote in Fridays opinion.

Supporters of the research said they were thrilled. This ensures that Americas best scientists can continue to move this work forward despite ideologically driven attempts to derail it, said Amy Rick, president of the Coalition for the Advancement of Medical Research.

There are other types of stem cells, including so-called adult stem cells, found in everyone's bodies. But scientists say they don't have the same powerful properties as embryonic stem cells. Labs are also working to re-program ordinary cells to behave like embryonic cells. A deeply divided Congress has decided not to weigh in on the issue until elections give one party or the other more power.

Maggie Fox, Senior Writer and Maggie Fox, Senior Writer

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Court rules controversial stem cell research is legal

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Legal Issues in Stem Cell Therapy in the U.S. – Inventus Law

Friday, June 19th, 2020

Legal Issues in Stem Cell Therapy in the U.S.Jul 30, 2019 | Fred Greguras

My wife has had osteoarthritis, sometimes called wear-and-tear arthritis, in both of her knees since 2011. She first saw an advertisement for stem cell treatment in 2012 and continued to do research on the treatment. Late in 2018, after ultrasounds on her knees and consultation with several doctors and clinics in California and Colorado, she decided to have stem cell therapy that could regenerate the meniscus cartilage of her knees. Such therapy is a minimally invasive procedure that has the potential to slow the progress of the arthritic damage, repair joint cartilage and avoid or delay invasive knee replacement surgery. Such therapy can help the body repair itself naturally.

We thought it was best to act now before her knees worsened since the earlier the stem cell treatment began, the greater the chances for a successful outcome there would be. The present lack of health insurance coverage was considered, but the treatment cost was reasonable given the potential to avoid more invasive surgery and the timing of treatment. Most insurance plans, including Medicare, define the procedure as experimental and investigational and do not cover the therapy.

Based on her research, my wife selected Dr. Jason Glowney of Boulder Biologics to perform the treatment. Her treatment took place in the second week of January, 2019, as an outpatient at a hospital in Boulder, Colorado. The procedure was completed in under four hours. She was injected with her own stem cells (called an autologous donation), reducing the risk of immune rejection and other complications.

The medical team used ultrasound to identify the best sites for injection into the damaged tissue of her knees. The same needle remained in each knee site during the treatment, but the injections in each step described below were all done with separate syringes in sequence. There was no mixture of any of the multiple components in a single syringe.

The doctor gave her light oral sedation to help her relax for the procedure and used local anesthetic at the points of cell harvest and injection. No general anesthetic was administered. The procedure began with a harvest of platelet-rich plasma (PRP) from her blood. Her blood was quickly processed through a centrifuge to separate the blood and concentrate the platelets in the plasma, which was then injected to fertilize the knee sites to enhance cell growth. The concentrated platelets contain growth factors along with bioactive proteins that help initiate and stimulate tissue repair and regeneration. (In late May, 2019, she had another PRP injection to stimulate and enhance the growth of the stem cells.)

The next step in the procedure was to harvest her bone marrow, centrifuge it into an injectable volume of aspirate concentrate and then inject the concentrate in both knees. The bone marrow aspirate contains stem cells that can help regenerate bone and cartilage.

The adipose (fat-derived) stem cells used in the next step compliment the bone marrow stem cells. The adipose cells were harvested by a minimally invasive liposuction procedure, centrifuged to isolate the cells and then injected in both knees. The fat on our bodies can be a rich source of stem cells.

Hundreds of thousands of cells were harvested and injected in each step in order to have an adequate number of stem cells for the treatment. The stem cells decide whether to differentiate into bone, meniscus or other cartilage or to simply renew.

My wife was given antibiotic (doxycycline) tablets to take at the end of the procedure and, for a period thereafter, to assist the differentiation process and to help decrease cartilage degradation.

As discussed in more detail below, the doctors procedure was designed to involve only simple human cellular and tissue products from the same patient and not to be a new biological product or drug which requires FDA approval. The procedure would be a new biological product or drug requiring FDA approval if there had been more than minimal manipulation of each component part. Even a mixture of a patients own stem cells and an antibiotic administered from the same syringe would be deemed a new biological product or drug by the FDA.

The doctor gave my wife guidelines for physical activity and medications during the post-injection period. The guidelines were designed to promote the growth of the stem cells to regenerate tissue. The cells are fragile, and she had to be careful not to cause too much stress or shearing on them which could impede growth. Her pain was intense during the first 24 hours, and she stayed in bed much of the time. She used a walker for about the first week. She started physical therapy about six days after the injections with the doctors approval. The doctor recommended that she not take any anti-inflammatory medications (like ibuprofen or motrin), for six weeks since they could impede the differentiation of the stem cells. The doctor advised her that most patients dont feel any knee improvement for at least three weeks and possibly for up to six to eight weeks. If there is no improvement by the six-month point after the injections, then the therapy has not worked.

A self-reporting instrument is used for assessing a patients knee status. The 33 items measured are intended to represent all major indicators of knee status. My wifes measures are all very positive at this six-month point after the procedure. The measurement factors include: (1) knee symptoms such as knee swelling, stiffness and frequency of pain; (2) amount of pain in activities such as walking, standing and going up and down stairs; and (3) degree of difficulty in activities such as walking, bending down and going up and down stairs. Each item is rated on a five-point scale relating to the extent of its occurrence or severity during the past week.

Stem Cell Background

Stem cells are different from other cell types in our bodies because they are capable of renewing (copying) themselves through cell division, sometimes after long periods of inactivity. Stem cells also have the potential to differentiate into other cell types in our body. When a stem cell divides, each new cell has the potential either to remain a stem cell or to differentiate into more specialized cells that form the bodys tissues and organs. In some organs, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, stem cells only divide under special conditions.

There are several types of stem cells that are formed at different times in our lives or come from different places in our body. Embryonic stem cells (ESCs) exist in the embryo only at the earliest stages of human development. ESCs are pluripotent, meaning they have the potential to differentiate into almost all cell types in the body. There are social and ethical issues relating to the use of ESCs, since harvesting the cells causes the destruction of an embryo. Many countries, including the U.S., have government-imposed restrictions on either ESC research or the production of new ESC lines.

Somatic or adult non-embryonic tissue-specific stem cells (ASCs) exist in specific tissues throughout the body after early human development. The stem cells injected into my wifes knees were ASCs. ASCs are multipotent, meaning they can differentiate into more than one type of specialized cell of the body, but not all types. ASCs are generally limited to differentiating into cell types of their tissue of origin, which can help with the replacement of cells from damaged tissue. ASCs can be an autologous stem cell donation, which is less likely to be rejected.

Amniotic stem cells (AMSCs) exist in the amniotic sac, which surrounds a baby in the uterus and remains until the babys birth. AMSCs are harvested right after the mother gives birth, without harming the baby. Some clinics make exaggerated claims about the therapeutic potential of ASMCs. AMSCs, however, are also multipotent, and the tissues they can differentiate into are substantially the same as stem cells from adipose (fat) and bone marrow. AMSCs exist only for a limited time, but adipose and bone marrow ASCs continue to be produced throughout our lives and can be harvested from the patient seeking therapy.

Some tissues and organs contain small amounts of ASCs whose function is to replace cells from that same tissue that deteriorate over time or are damaged by injury. For example, blood-forming stem cells in bone marrow can differentiate into red blood cells, white blood cells and platelets. However, blood-forming stem cells dont generate liver or lung or brain cells, and stem cells in other tissues and organs dont generate red or white blood cells or platelets.

Pluripotent stem cells have great therapeutic potential but still have major technical issues. Scientists cant control their differentiation into the many types of cells in the body which can result in unwanted tissue such as tumors. Since such stem cells are not from the recipient, they may also lack the compatibility needed to prevent rejection by the immune system.

Over 10 years ago, researchers identified conditions that enabled some specialized ASCs to be reprogrammed genetically back to an ESC-like state. The reprogrammed cells function similarly to ESCs and are called induced pluripotent stem cells (iPSCs). The iPSCs function similarly to ESCs, with the ability to differentiate into almost any cell of the body and to create an unlimited source of cells. iPSCs may ultimately help address the ethical concerns of ESCs and provide new potential for therapy, but there are still technical issues including whether they are actually equivalent to ESCs and the capability to control the differentiation process.

Legal Issues

FDA Approval Requirements

While the U.S. Food and Drug Administration (FDA) moves agonizingly slowly, its priority is human safety which is not the case in many other countries. Some other countries are the Wild West of stem cell therapy and have become medical tourism destinations for high-risk stem cell treatment. The FDA recommends that stem cell therapy is either FDA-approved or is done pursuant to an Investigational New Drug Application (IND), a clinical investigation plan submitted to and permitted to proceed by the FDA. There are many active clinical trials investigating the potential of ASCs listed on the U.S. National Institutes of Healths website.[1] Stem cell products approved by the FDA are listed on its web site.[2] There is no FDA-approved therapy involving the transplantation of ESCs. ESCs must be not be added to an injection, such as PRP, before it goes into a human.

The FDA regulates human tissues intended for transplant under 21 C.F.R. Part 1271: Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). Cellular and tissue-based therapies are regulated by the Office of Cellular, Tissue and Gene Therapies within the FDA Center for Biologics Evaluation. There are two primary regulatory pathways for these products. Cellular therapy products that meet all the criteria in 21 CFR 1271.10(a) are regulated solely as HCT/Ps and are not required to be licensed, approved or cleared by the FDA. These products are often referred to as 361 products because they are regulated solely under Section 361 of the Public Health Service Act (PHSA).[3] The regulatory purpose for such products is to prevent the introduction, transmission and spread of communicable diseases.

If a cellular therapy product does not meet all the criteria in 21 CFR 1271.10(a), it is regulated as a drug, device and/or biological product under the Federal Food, Drug and Cosmetic Act (FDCA)[4] and Section 351 of the PHSA (a 351 product). The FDA requires premarket approval for such a product. The criteria that determine whether a product is a Section 361 HCT/P or a Section 351 biological product include, primarily, whether a product has been minimally manipulated and is intended for homologous use. Stem cell therapies generally do not satisfy these criteria and therefore are usually regulated as Section 351 products.

In the 2014 decision, United States of America v. Regenerative Sciences, LLC,[5] the court held that a mixture of autologous ASCs and other components was a 351 product and subject to FDA approval. Regenerative Sciences, LLC argued that its process did not create a mixture but only expanded the patients own cells and, therefore, was a simple 361 product which does not require FDA approval. The FDAs position is that any process involving human cellular and tissue products that includes culturing, expansion and added growth components or antibiotics requires FDA approval as a biological product or new drug because the process constitutes significant manipulation.

The FDA alleged that the product was a 351 product for failure to comply with its minimal manipulation provisions and because the resulting stem cells were not intended for homologous use. Homologous use means that a human cellular or tissue product is used clinically in a manner that is essentially the same as the natural function. The homologous use definition is strictly interpreted by the FDA, so that most innovative ways to use stem cells to potentially treat patients would be through non-homologous usage. The FDA will generally define even modestly different uses as non-homologous.

There are many clinics offering stem cell therapy in the U.S., some which carefully follow the law and others which do not. The FDA has only has brought a small number of enforcement actions because of resource limitations and proof concerns. Enforcement usually occurs in high-profile situations where a patient has died or is severely harmed.

Intellectual Property Issues

The two important types of intellectual property protection relating to stem cell therapy are trade secret and patent protection. For example, the cell harvesting techniques and settings for the centrifuge processing in each step in my wifes treatment can be protected as trade secret know-how. The culturing and cocktails of growth factors and/or other components in the Regenerative Sciences, LLC case are another example.

There are many patents registered with the USPTO that contain the term stem cell, but recently, many human stem-based inventions have been rejected for not being eligible patentable subject matter. Patent-eligible subject matter is defined in 35 U.S.C. Section 101 as: Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. There are three exceptions to subject matter eligibility: laws of nature, physical phenomena and abstract ideas.[6] The laws of nature exception has been the basis for rejection of patent eligibility for certain stem cell-related inventions.

There were two important court decisions in 1977 and 1980 relating to patent protection eligibility for the biotechnology industry.[7] The USPTO issued many stem cell patents following these decisions.

Several Supreme Court decisions in the past 10 years, however, have narrowed the scope of patent-eligible subject matter under Section 101.[8] In the Mayo decision, the Court held the invention was not patentable, stating that it effectively claimed the underlying laws of nature. The Court held that a claim that encompasses the use of a natural law must also include additional elements, sometimes referred to as an inventive concept, sufficient to ensure that the patent amounts to significantly more than a patent upon the natural law itself.

The scope of patent-eligible subject matter was further narrowed in the Myriad decision, which held that a naturally occurring DNA segment is a product of nature and not eligible for patent protection merely because it had been isolated. The Court looked for markedly different characteristics from any found in nature of the isolated gene to determine patent eligibility. The changes resulting from isolation of a gene sequence were considered incidental and not enough to make the isolated gene markedly different.

Three recent decisions in the Federal Circuit indicate that method-of-treatment claims that may involve a law of nature are patent-eligible.[9] Each of the patents required an affirmative treatment step. The decisions seem to hold that a patent directed to detecting a condition in a patient is not Section 101-eligible under Mayo, while a patent directed to using that detection to change some aspect of the patient is eligible. The patent may have been based upon the inventors discovery of a law of nature but the patent did not simply claim that law of nature. Rather, it was directed to a specific method of treatment.

The United States Patent and Trademark Office (USPTO) has published guidelines for patent examiners on how to analyze a claim which includes a nature-based product for patent eligibility.[10] Claims are to be examined for an inventiveness that has markedly different characteristics from naturally occurring products. Patent eligibility for a natural product is to be determined primarily by whether the claimed product possesses any structural, functional and/or other properties that represent markedly different characteristics from the natural counterpart. If the claim includes a nature-based product that has markedly different characteristics, then the claim is not within the product of nature exception. On the other hand, if the claim includes a nature-based product that does not have markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim is within the product of nature exception and is not eligible for patent protection.[11]

The first step in the analysis is to select the counterpart(s) to compare to the nature-based product. The second step is to identify characteristics to compare, since the analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart. Characteristics can be expressed as the nature-based products structure, function and/or other properties, and are evaluated on a case-by-case basis. The final step is to compare the characteristics of the claimed nature-based product to the characteristics of its naturally occurring counterpart in its natural state to determine if the characteristics of the claimed product are markedly different. If there is a change in at least one characteristic resulting from, or produced by, the patent applicants efforts or influences, then the change will generally be found to be a markedly different characteristic.

Consumer Protection

My wife was provided with disclosures from the doctors office and requested to sign a number of consents and waivers as a condition of receiving therapy. One of the waivers was a no assurance of successful treatment agreement.

State laws protecting consumers against deceptive advertising are applicable to representations about the effectiveness of stem cell treatment. Several state legislatures have debated additional protections for consumers relating to such treatment. California enacted a consumer protection law in late 2017 that requires clinics offering stem cell treatments to disclose if the treatment is not approved by the FDA.

The Federal Trade Commission (FTC) and FDA are pursuing enforcement actions in selected cases that may cause stem cell clinics to be more careful about their representations and activity. In late 2018, the FTC settled charges with a California-based physician and his businesses of deceptively advertising that amniotic stem cell therapy can treat serious diseases.[12] The settlement prohibits the defendants from making any health claims in the future unless the claims are true and supported by competent and reliable scientific evidence. This was the first enforcement action brought by the FTC against a stem cell clinic.

In early June, 2019, a federal judge granted the FDA an injunction to prevent the U.S. Stem Cell Clinic (based in Florida) from offering treatments using adipose stem cells injected into the spinal cords of patients to treat Parkinsons disease, chronic obstructive pulmonary disease and other serious conditions.[13] The court held that the defendants misbranded the possible therapeutic effects. The court also determined the clinic failed to prevent microbiological contamination of products which put patients at risk for infections.

Conclusion

As indicated, the status measures for my wifes knees are all very positive six months after the procedure. She is glad she tried it. I would try the therapy if I have problems with my knees.

The FDA will continue to move slowly to approve stem cell therapies since its priority is human safety. Some other countries have become medical tourism destinations for high-risk stem cell treatment. Many of the claims of such foreign clinics and of some clinics in the U.S. are medically unproven. The FDA and other regulators will continue to bring enforcement actions based on the severity of patient risk and available resources. Obtaining patent protection for stem cell-related inventions is challenging because of the subject matter eligibility issue under Section 101. The recent method-of-treatment decisions in the Federal Circuit may provide a helpful eligibility precedent for some inventions.

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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.

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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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