StemCell Therapy

June 8, 2017 This image shows human heart muscle cells growing in the 3D tissue structure. The cells have been stained with fluorescent molecules to identify the nuclei in blue, and cardiac-specific protein, in green. Credit: Agency for Science, Technology and Research (A*STAR), Singapore

Researchers at the Institute of Bioengineering and Nanotechnology (IBN) of A*STAR have engineered a three-dimensional heart tissue from human stem cells to test the safety and efficacy of new drugs on the heart.

"Cardiotoxicity, which can lead to heart failure and even death, is a major cause of drug withdrawal from the market. Antibiotics, anticancer and antidiabetic medications can have unanticipated side effects for the heart. So it is important to test as early as possible whether a newly developed drug is safe for human use. However, cardiotoxicity is difficult to predict in the early stages of drug development," said Professor Jackie Y. Ying, Executive Director at IBN.

A big part of the problem is the use of animals or animal-derived cells in preclinical cardiotoxicity studies due to the limited availability of human heart muscle cells. Substantial genetic and cardiac differences exist between animals and humans. There have been a large number of cases whereby the tests failed to detect cardiovascular toxicity when moving from animal studies to human clinical trials.

Existing screening methods based on 2-D cardiac structure cannot accurately predict drug toxicity, while the currently available 3-D structures for screening are difficult to fabricate in the quantities needed for commercial application.

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To solve this problem, the IBN research team fabricated their 3-D heart tissue from cellular self-assembly of heart muscle cells grown from human induced pluripotent stem cells. They also developed a fluorescence labelling technology to monitor changes in beating rate using a real-time video recording system. The new heart tissue exhibited more cardiac-specific genes, stronger contraction and higher beating rate compared to cells in a 2-D structure.

"Using the 3-D heart tissue, we were able to correctly predict cardiotoxic effects based on changes in the beating rate, even when these were not detected by conventional tests. The method is simple and suitable for large-scale assessment of drug side effects. It could also be used to design personalized therapy using a patient's own cells," said lead researcher Dr Andrew Wan, who is Team Leader and Principal Research Scientist at IBN.

The researchers have filed a patent on their human heart tissue model, and hope to work with clinicians and pharmaceutical companies to bring this technology to market.

This finding was reported recently in the Biofabrication journal.

Explore further: Stem cell-based screening methods may predict heart-related side effects of drugs

More information: Hong Fang Lu et al. Engineering a functional three-dimensional human cardiac tissue model for drug toxicity screening, Biofabrication (2017). DOI: 10.1088/1758-5090/aa6c3a

Coaxing stem cells from patients to become heart cells may help clinicians personalize drug treatments and prevent heart-related toxicity.

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Human heart tissue grown from stem cells improves drug testing - Medical Xpress

Bioquark, a life science company, hopes to bring people declared as clinically brain-dead back to life through stem cells. Trials will be initiating soon.

With rapid increases in technology from human head transplants to reversing symptoms of ageing, researchers are surely setting high goals.

With their latest discovery of reversing death, the Philadelphia-based biotech company is supposed to work on its project by the end of this year.

Though the trials were expected to begin in 2016 in India, the regulators had it shut down. Now, the researchers plan on conducting considerably similar plan and will enroll 20 patients who will go through different treatments.

With the stem cells being cut off from the patients own fat or blood, a stem cell injection will be given to the patients first. Then, a protein blend will be injected into the spinal cord which is supposed to advance new neuron growth. With the intention of promoting neuron communications, the laser therapy and nerve stimulation will be conducted next for another 15 days, reported Futurism.

In the mean time, the researchers will examine behavior and EEGs both to see any indications of the treatment causing any alterations.

However, a few researchers have raised questions regarding the informed consent from the patients. They question about how will the researchers go forth with their trails and how would they complete the paperwork considering that the patients is already brain dead?

Another question raised was what if the brain activity came back and what would be the patients mental state? And what could be the possible outcomes other than extreme brain damage?

According to Science Alert, back in 2016, Stat News reported neurologist Ariane Lewis and bioethicist Arthur Caplan stated in Critical Care the trail as dubious, has no scientific foundation and suffers from an at best, ethically questionable, and at worst, outright unethical nature.

Researchers also doubt the companys techniques and believe there is no way this technique could work on someone who is brain-dead.

Researchers claim, The technique relies on there being a functional brain stem one of the structures that most motor neurons go through before connecting with the cortex proper. If there's no functional brain stem, then it can't work.

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American company brings dead people back to life - Business Recorder (press release) (registration) (blog)

For any given medical problem, it seems, theres a research team trying to use stem cells to find a solutionBut in one study expected to launch later this year, scientists hope to use stem cells in a new, highly controversial way to reverse death.

The idea of the trial, run by Philadelphia-based Bioquark, is to inject stem cells into the spinal cords of people who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain.

The ultimate goal: to grow new neurons and spur them to connect to each other, and thereby bring the brain back to life.

This isnt the first start for the trial. The study launched in Rudrapur, India, in April 2016 but it never enrolled any patients. Regulators shut the study down in November 2016 becauseIndias Drug Controller General hadnt cleared it.

Now, the company is in the final stages of finding a new location to host trials. The company will announce a trial in Latin America in coming months.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: Resurrected: A controversial trial to bring the dead back to life plans a restart

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Back to life: Can controversial stem cell treatment revive brain-dead patients? - Genetic Literacy Project

A Philadelphia-based company, Bioquark, has revealed it is working on a new stem cell therapy that will attempt to revive brain-dead people. The first test is scheduled to begin this year in an undisclosed location in Latin America, the Daily Mail reported.

Ira Pastor, CEO of Bioquarkrevealed his company has developed a series of injections that are capable of rebooting the human brain. He also mentioned that the company aims to test these injections on humans this year, the report added.

Pastor further said his company does not plan to conduct thesetests on animals.

Read:How Do You Know When Someone Is Dead? Experts Question Guidelines To Determine Death

At first, Pastor along with his co-worker Himanshu Bansal had planned to conduct this experiment in a remote part of India. For this, they had gathered 20 subjects. But, before they couldstart with their experiment,it was blocked by the Indian Council of Medical Research (ICMR) without stating a proper reason. The pair was asked to conduct their research elsewhere, after which they decided to go ahead with their research in Latin America, the report stated.

In the first phase of the experiment named First In Human Neuro-Regeneration & Neuro-Reanimation, scientists will first collect stem cells from the subjects blood or fat and then inject it back into their body.

The next step would be injecting a dose of peptides into the subjects spinal cord. A peptide is a compound consisting of two or more amino acids linked in a chain. Molecules small enough to be synthesized from the constituent amino acids are, by convention, called peptides.

According to scientists, this would speed up the growth of new neurons in clinically brain-dead patients.

The subject would then be kept under observation for a period of 15 days during which they will be subjected to nerve stimulation involving laser technology and median nerve stimulation. Nerve stimulation is the process of stimulating nerves for therapeutic purposes using electric current produced by a device.

During this simulation process, the subject will constantly be monitored using MRI scans for any signs of life.

The mission of the Project is to focus on clinical research in the state of brain death, or irreversible coma, in subjects who have recently met the Uniform Determination of Death Act criteria, but who are still on cardiopulmonary or trophic support a classification in many countries around the world known as a "living cadaver, Pastor had said last year.

However, Pastor's idea was not welcomed by all medical experts. There is no way this technique could work on someone who is brain-dead. The technique relies on there being a functional brain stem one of the structures that most motor neurons go through before connecting with the cortex proper, Dr. Ed Cooper, who has studied and authored several studies on brain stimulation, told Stat News.

If there's no functional brain stem, then it can't work, he further said.

Meanwhile, several questions related to the research have surfaced, one of them being how do researchers complete paperwork for the experiment when the subject is clinically dead? Or should families of the subjects hope for an incredibly long-shot cure? Although the answers to these questions are far off, Pastorsaid:While the complete recovery in such patients is indeed a long term vision of ours and a possibility that we foresee with continued work along this path, it is not the core focus or primary endpoint of this first protocol.

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Can We Cheat Death? US Firm Aims To Resurrect Brain-Dead ... - International Business Times

Thy dead shall live, my dead bodies shall ariseawake and sing, ye that dwell in the dustfor Thy dew is as the dew of light, and the earth shall bring to life the shades. Isaiah 26:19 (The Israel Bible)

(Shutterstock)

A biomedical company is set to begin experiments using stem cells to revive brain dead patients in a manner that troubles theologians, who question whether this attempt to preempt the Messianic resurrection of the dead should be permitted. One prominent rabbi takes it even further, pointing out the clear and obvious flaw that destines the project to failure.

Bioquark, a biomedical startup based in Philadelphia, recently announced that they will begin experiments later this year on patients who have been declared clinically brain dead. The trial will involve a multi-pronged approach, involving injecting stem cells and peptides into the spinal cords, electrical nerve stimulation, and laser therapy. The researchers hope this will grow new neurons and spur them to connect to each other, bringing the brain back to life.

If they succeed, they will be violating a sacred Biblical tenet, Rabbi Moshe Avraham Halperin from the Science and Technology Torah Law Institute, which investigates modern technology within a religious Jewish framework, told Breaking Israel News.

If they are able to revive a person from total brain death, it will be considered techiyat hamaytim (resurrection of the dead), said Rabbi Halperin. Torah law puts limits on man, forbidding him from some areas which are strictly divine. Reviving the dead is one of them.

The study is not only problematic for theologians. It raises many issues in medical ethics. A similar experiment led by Bioquark in India in 2016 was not cleared by Indias Drug Controller General. Amar Jesani, editor of the Indian Journal of Medical Ethics in Mumbai, cautioned that even partial success would traumatize families that had come to terms with a situation they believed irreversible. In point of fact, no families permitted their loved ones to be part of the experiment.

Bioquark plans to try again later this year in an undisclosed location in Latin America. If successful, the experiment would be a medical breakthrough bordering on a miracle. A survey published in 2010 that described cases covering 13 years found that there has never been a single case of a person regaining brain function after all the criteria determining full brain death have been met.

This is like using genetics to create a new form of life, said Rabbi Halperin. There are realms that are strictly divine. Resurrection of the dead is clearly possible. It is definitely going to happen after the Messiah, but it restricted to God.

Rabbi Yosef Berger,rabbi of King Davids Tomb on Mount Zion in Jerusalem, stated that not only was the experiment forbidden, but it had no chance of success. He cited the 13 Principles of Faith established by Rabbi Moses ben Maimon, the prominent 12th century Torah authority known by the acronym Rambam. The last of his principles states, I believe by complete faith that there will be a resurrection of the dead at the time that will be pleasing before the Creator.

The Rambam states that we must believe that the resurrection of the dead will happen when it is Gods will for it to take place and at no other time, Rabbi Berger stressed to Breaking Israel News. Not only does this effort by scientists go against this principle of faith, but we know that true resurrection can only happen by Divine will.

Resurrection of the dead is described in depth, and it is proof of Gods rule over the physical world. But it is also stated that before the Messiah, there is no return from the grave.

He added that the phenomenon of death will vanish after the resurrection of the dead, citing the book of Daniel.

And many of them that sleep in the dust of the earth shall awake, some to everlasting life, and some to reproaches and everlasting abhorrence. Daniel 12:2

The scientists believe they are masters over life and death, said Rabbi Berger. Just as they cannot create eternal life, they will find that they are not masters over death. For that, there is only One.

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Is New Scientific Trial to Revive the Dead a Threat to God's Final Resurrection of Believers? - Breaking Israel News

In BriefBioquark is about to begin a trial that will attempt to bringbrain-dead patients back to life using stem cells. However, thetrial is raising numerous scientific and ethical questions forother experts in the field. Back From The Dead

Researchers seem to be setting their sights on increasinglylofty goals when it comes to the human body from the worlds first human head transplant, to fighting aging, and now reversing death altogether. Yes, you read that right. A company called Bioquarkhopes to bring people who have been declared clinically brain-dead back to life. The Philadelphia-based biotech company is expected to start on the project later this year.

This trial was originally intended to go forward in 2016 in India, but regulators shut it down. Assuming this plan will be substantially similar, it will enroll 20 patients who will undergo various treatments. The stem cell injection will come first, with the stem cells isolated from that patients own blood or fat. Next, the protein blend gets injected directly into the spinal cord, which is intended to foster growth of new neurons. The laser therapy and nerve stimulation follow for 15 days, with the aim of prompting the neurons to make connections. Meanwhile, the researchers will monitor both behavior and EEGs for any signs of the treatment causing any changes.

While there is some basis in science for each step in the process, the entire regimen is under major scrutiny. The electrical stimulation of the median nerve has been tested, but most evidence exists in the form of case studies. Dr. Ed Cooper has described dozens of these cases, and indicates that the technique can have some limited success in some patients in comas. However, comas and brain death are very different, and Bioquarks process raises more questions for most researchers than it answers.

One issue researchers are raising about this study is informed consent. How can participants in the trial consent, and how should researchers complete their trial paperwork given that the participants are legally dead and how can brain death be conclusively confirmed, anyway? What would happen if any brain activity did return, and what would the patients mental state be? Could anything beyond extreme brain damage even be possible?

As reported by Stat News, In 2016, neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan wrote in Critical Care that the trial is dubious, has no scientific foundation, and suffers from an at best, ethically questionable, and at worst, outright unethical nature. According to Stat News, despite his earlier work with electrical stimulation of the median nerve, Dr. Cooper also doubts Bioquarks method, and feels there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem one of the structures that most motor neurons go through before connecting with the cortex proper. If theres no functional brain stem, then it cant work.

Pediatric surgeon Charles Cox, who is not involved in Bioquarks work, agrees with Cooper, commenting to Stat News on Bioquarks full protocol, its not the absolute craziest thing Ive ever heard, but I think the probability of that working is next to zero. I think [someone reviving] would technically be a miracle.

Pastor remains optimistic about Bioquarks protocol. I give us a pretty good chance, he said. I just think its a matter of putting it all together and getting the right people and the right minds on it.

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Scientists Hope to Use Stem Cells to Reverse Death in Controversial Study - Futurism

Stress and being overburdened may not give you a near-fatal illness," Susan Doherty says, "but in my opinion it can turn the key and open the gate." Pierre Obendrauf / Montreal Gazette

Death is a great teacher and Susan Doherty should know.

The Westmount author and fitness instructor has stared it in the face, unblinking, having gone to the brink several times in the last couple of years as she found herself in the clutches of a very rare, and very deadly, illness.

And death, she says, or the very real prospect of it, has taught her so very much about life.

Now, as she approaches the significant one-year anniversary of her stem cell transplant at the Royal Victoria Hospital on June 2, she hopes some of those lessons can be shared with others facing daunting obstacles.

Doherty is one of those people best described as a force of nature. Even at the height of her life-threatening illness and harrowing treatments, one of her doctors recalled she took such swift power walks through the hospital that it was challenging keeping up with her.

It is her unstoppable nature that very likely got her through a two-year battle with HLH, Hemophagocytic Lymphohistiocytosis, a life-threatening immunodeficiency.

So rare and unknown is this blood disease that when she was given the diagnosis by hematologist-oncologist April Shamy and her team at the Jewish General Hospital on Aug. 6, 2015, her blood had to be flown to Toronto because the test required for confirmation is not available here.

HLH is not cancer, but its treated like cancer, and Doherty had to begin chemotherapy within hours. Left untreated, a patient can die within 60 days of multi-organ failure and they were not sure where Doherty was on that trajectory.

Doherty, 59, is one of the first adults in Quebec to receive a stem cell transplant for HLH.

With HLH, the immune system becomes overactive and poorly controlled, which is potentially damaging to all vital organs and blood cells.

When I say how fortunate I am to have had the diagnosis in time, I feel truly blessed. People often die before they even know whats wrong, Doherty said.

Her medical crisis began on Feb. 25, 2015, with the onset of chills and a racing heart. An hour later she felt fine and chalked it up to wintry weather.

I felt like something evil had passed through my body and left without a trace, she recalled.

In reality, it was more like something evil had entered her body and decided to stay.

One doctor blamed it on anxiety after all, she was in the throes of moving her sick mother while she nursed a broken arm; her mother-in-law had end-stage Alzheimers disease; she was working on the final edit of her first novel, A Secret Music; she was teaching several fitness classes and she was volunteering in the schizophrenia ward at the Douglas Hospital three times a week.

Stress and being overburdened may not give you a near-fatal illness, but in my opinion it can turn the key and open the gate, Doherty said.

In August, she developed a high fever and the right side of her face went numb. Over the next several days, Doherty had every test imaginable.

She describes the day she got her diagnosis as both the scariest and most spiritual of her life. Surrounded by her husband, Hal Hannaford, and her children, Alisse and Reid, Doherty began my recovery with positivity and the certainty my health would return.

She maintained a demanding exercise and meditation regime and decided very early on in her journey that it took just as much energy to be positive as to be negative.

The physical pain of what I went through is nothing compared to the existential pain, she said.

Her doctors recognized her unflagging optimism as inspirational.

The way she confronted and navigated her course was extraordinary, said Shamy. She tackled every day with a smile and an exemplary positive attitude. She has been an inspiration to all of us and we have been enriched through meeting her.

Doherty successfully completed chemotherapy and went into remission for 77 days.

Then, in January 2016, HLH came back fast and furious. Shamy told her she would need a stem cell transplant if she had any hope of surviving.

Doherty had to repeat the chemotherapy, plus additional brain chemotherapy. In Montreal, only the Royal Victoria and Maisonneuve-Rosemont hospitals even have stem cell transplant programs, and Doherty was fortunate to be accepted at the Vic.

Doctors told her she had a 50 per cent chance of survival. But Doherty always told everyone her chances were 100 per cent; she just knew she would be in the good pile.

A donor was found in Germany (so Doherty made a playlist of German music to inspire her during the transplant), and she had to prepare for 50 days in isolation.

Doherty packed only the necessities: her weights, a yoga mat, running shoes, a wooden angel and her lucky shamrock. She was able to get a miniature spin bike in her room at the Glen. She focused on remaining positive, but there were moments when it was necessary to go into her bathroom, close the door and sob.

Often awake for 24 hours, there was a lot of time to fill. Exercise every day, even the awful days, was a must. It built resilience, she believes.

Your hair falls out, your muscles waste from the steroids, you have ulcers all along your digestive tract. You feel ugly, she recalled.

But there was Hannaford, every morning, with a cinnamon latt and his ability to make her feel beautiful.

June 2 last year was transplant day. As the infusion of stem cells began, she thought about the selflessness of her German donor, the countless emails from supportive friends and family that had lifted her spirits and all she had learned throughout her ordeal.

You get better faster if you have good friends and a loving family, she said. She says her debt to science is infinite but recognizes that her unshakable faith was also instrumental as she celebrates this one-year miracle anniversary.

Unbelievably, Doherty never felt sorry for herself. She believes her battle was nothing compared to the people with schizophrenia she works with and that her mission to help them is why she survived.

No matter what you are facing in life, you can always choose your attitude. Always, Doherty said. Outcomes are outcomes. But living with happiness is a choice.

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Cower in the face of death? Not on your life, Westmount woman says - Montreal Gazette

F

or any given medical problem, it seems, theres a research team trying to use stem cells to find a solution. In clinical trials to treat everything from diabetes to macular degeneration to ALS, researchers are injecting the cells in efforts to curepatients.

But in one study expectedto launch later this year, scientists hope to use stem cells in a new, highly controversial way to reverse death.

The idea ofthe trial, run by Philadelphia-based Bioquark, isto inject stem cells into the spinal cords of people who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain.

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The ultimate goal: to grow new neurons and spur them to connect to each other, and thereby bring the brain back to life.

Its our contention that theres no single magic bullet for this, so to start with a single magic bullet makes no sense. Hence why we have to take a different approach, said Ira Pastor, CEO of Bioquark.

A dogged quest to fix broken spinal cords pays off with new hope for the paralyzed

But the scientific literature scarce as it is seems to show that even several magic bullets are unlikely to accomplish what Bioquark hopes itwill.

This isnt the first start for the trial. The study launched in Rudrapur, India, in April 2016 but it never enrolled any patients. Regulators shut the study down in November2016 because, according to Science, IndiasDrug Controller General hadnt cleared it.

Now, Pastor said, the company is in the final stages of finding a new location to host trials. The company willannounce a trial in Latin America in coming months, Pastor told STAT.

If that trial mirrors the protocol for the halted Indian one, itll aim to enroll 20 patients wholl receive a barrage of treatments. First theres the injection of stem cells isolatedfrom the individuals own fat or blood. Second, theres a peptide formula injected into the spinal cord, purported to help nurture new neurons growth. (The company has tested the same concoction, called BQ-A, in animalmodels of melanoma, traumatic brain injuries, and skin wrinkling.) Third, theres a regimen of nerve stimulation and laser therapyover 15 days to spur the neurons to form connections. Researcherswilllook to behavior and EEG for signs that the treatment is working.

But the process is fraught with questions. How do researchers complete trial paperwork when the person participating is, legally, dead? (In the United States, state laws most often define death as the irreversible loss of heart and lung or brain function.) If the person did regain brain activity, what kind of functional abilities would he or she have? Are families getting their hopes up for an incredibly long-shot cure?

Answers to most of those questions are still far off. Of course, many folks are asking the what comes next? question, Pastor acknowledged. While full recovery in such patients is indeed a long term vision of ours, and a possibility that we foresee with continued work along this path, it is not the core focus or primary endpoint of this first protocol.

No real template exists to know whether this approach might work and its gotten some prominent backlash. Neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan wrote in a 2016 editorial that the trial borders on quackery, has no scientific foundation, and gave families a cruel, false hope for recovery. (Exploratory research programs of this nature are not false hope. They are a glimmer of hope, Pastor responded.)

The company hasnt tested the full, four-pronged treatment, even in animal models. Studies have evaluated the treatments singly for other conditions stroke, coma but brain death is a quite different proposition.

Stem cell injections to the brain or spinal cord have shown some positive results for children with brain injuries; trials using similar procedures to treat cerebral palsy and ALS have also been completed. One small, uncontrolled studyof 21 stroke patients found that they recoveredmore mobility after they received an injection of donor stem cells into their brains.

On transcranial laserdevices, the evidence is mixed. The approach has been shown to stimulate neuron growth in some animal studies. However, a high-profile Phase 3 study of one such device in humans was halted in 2014 after it showed no effect on 600 patients physical capabilities as they recovered from a stroke. Othertrialsto revive people from comasusing laser therapy are underway.

The literature around electrical stimulation of the median nerve whichbranches from the spinal cord downthe arm and to the fingers primarily consists of case studies.Dr. EdCooper wrote some of those papers, one of which described dozens of patients treated in his home state of North Carolina, including 12 who had a Glasgow Coma Score of 4 an extremely low score on the scale. With time (and with the nerve stimulation), four of those 12people made a good recovery, the paper described; others were left with minor or major disabilities after their coma.

Mini-me brains-in-a-dish mimic disease, raise hope for eventual therapies

But Cooper, an orthopedic surgeon by training who worked with neurosurgeons on the paper, said unequivocally that there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem one of the structuresthat mostmotor neurons go through before connecting with the cortex proper. If theres no functional brain stem, then it cant work.

Pastor agreed but heclaimed the technique would work because there are a small nestofcells that still function in patients who are brain-dead.

Complicating such trials, there is noclear-cut confirmatory test for brain death meaning a recovery in the trial might not be entirely due to the treatment. Some poisons and drugs, for instance, can make people look brain-dead.Bioquark plans to rely on local physicians in the trials host country to make the declaration. Were not doing the confirmatory work ourselves, Pastor said, but each participant would have undergone a battery of tests considered appropriate by local authorities.

But asurvey of 38 papers published over 13 years found that, if the American Academy of Neurology guidelines for brain death had been met, no brain-dead people have ever regained brain function.

Of Bioquarks full protocol, its not the absolute craziest thing Ive ever heard, but I think the probability of that working is next to zero, said Dr. Charles Cox, a pediatric surgeon who has doneresearch with mesenchymal stem cells the type used in the trial at the University of Texas Health Science Center at Houston. Cox is not involved in Bioquarks work.

Some studies have found that cells from a part of thebrain called the subventricular zone can grow in culture even after a person is declared dead, Cox said. However, its unlikely that the trials intended outcome to havea stem cell treatment result in new neurons or connections would actually happen. Neurons would likely struggle tosurvive, because blood flow to the brain isalmost always lostin people whohave been declared brain-dead, Cox said.

But Pastor thinksBioquarks protocol will work. I give us a pretty good chance, he said. I just think its a matter of putting it all together and getting the right people and the right minds on it.

Cox is less optimistic. I think [someone reviving] would technically be a miracle, he said. I think the pope would technically call that a miracle.

Kate Sheridan can be reached at kate.sheridan@statnews.com Follow Kate on Twitter @sheridan_kate

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Resurrected: A controversial trial to bring the dead back to life plans a restart - STAT

The Scientist

Zika Grabs Neural Stem Cell Protein to Cause Damage The Scientist The presence of the Musashi-1 protein greatly increases production of Zika virus (green), making neural stem cells particularly vulnerable to cell death following viral infection. GENERATED BY THE GERGELY LABWhen the Zika virus enters neural stem cells ... New insights into how the Zika virus causes microcephalyMedical Xpress New insights into how Zika causes microcephalyWellcome Trust all 3 news articles »

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Zika Grabs Neural Stem Cell Protein to Cause Damage - The Scientist

"It's our contention that there's no single magic bullet for this, so to start with a single magic bullet makes no sense. Hence why we have to take a different approach," Bioquark CEO, Ira Pastor, told Stat News.

As Pastor told the Washington Post last year, he doesn't believe that brain death is necessarily a permanent condition, at least to start. It may well be curable, he argued, if the patient is administered the right combination of stimuli, ranging from stem cells to magnetic fields.

The resuscitation process will not be a quick one, however. First, the newly dead person must receive an injection of stem cells derived from their own blood. Then doctors will inject a proprietary peptide blend called BQ-A into the patient's spinal column. This serum is supposed to help regrow neurons that had been damaged upon death. Finally, the patient undergoes 15 days of electrical nerve stimulation and transcranial laser therapy to instigate new neuron formation. During the trial, researchers will rely on EEG scans to monitor the patients for brain activity.

This isn't the first time that Bioquark has attempted this study. Last April, the company launched a nearly identical study in Rudrapur, India. However, no patients enrolled and the study wound up getting shut down that November by the Indian government over clearance issues with India's Drug Controller General. Bioquark is reportedly nearing a deal with an unnamed Latin American country to hold a new trial later this year.

Whether the treatment will actually work is an entirely different matter. Bioquark admits that it has never actually tested the regimen, even in animals, and the various component treatments have never themselves been applied to brain death. They've shown some promise in similar cases like stroke, brain damage and comas but never actually Lazarus-ing a corpse.

"I think [someone reviving] would technically be a miracle," Dr. Charles Cox, a pediatric surgeon at the University of Texas Health Science Center at Houston, told Stat News. "I think the pope would technically call that a miracle."

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Researchers will attempt to 'reanimate' a corpse with stem cells - Engadget

June 1, 2017 by Peter Tarr Researchers have discovered that a chromatin-regulating protein called BPTF must be present for stem cells in the breast to perform their normal functions maintaining a supply of stem cells and seeding the breast with specialized new cells when needed, for instance, during pregnancy. At the mouse equivalent of mid-pregnancy, there is normally (left side) a proliferation of milk ducts (the small purple structures in both images). When BPTF is knocked out in mouse mammary stem cells early in pregnancy, however, there is a drastic decline in the number ductal structures (right side). Dos Santos and colleagues suggests that knocking out BPTF in breast cancer cells could suppress or kill them. Credit: dos Santos lab, CSHL

For years, cancer experts have realized that cancerous cells behave in certain ways like stem cells, unspecialized cells that when exposed to certain signals, can "differentiate."

When a stem cell differentiates, it starts down a one-way path that will result in its specialization and eventually its death. For instance, a stem cell in the breast can become a luminal cell, one of the breast's "milk factories." Such cells have a limited life span. Cancer cells resemble stem cells not because they can turn into other cell types, but because in developmental terms, they seem to go in the opposite direction: they begin to run through multiple layers of stop signs and barricades and just keep on multiplying.

Assistant Professor Camila dos Santos of Cold Spring Harbor Laboratory (CSHL) is studying stem cells in the breast for clues about what changes occur when normal breast cells become cancerous. Today, a team led by dos Santos, in collaboration with Assistant Professor William Pomerantz at the University of Minnesota and Professor Gregory Hannon of Cancer Research UK, Cambridge Institute, identify a protein that they show must be present in order for mammary stem cells to perform their normal functions.

When the researchers genetically removed or chemically inhibited the protein, called BPTF, stem cells could no longer maintain their "renewing" state and began to take on the character of specialized breast cellsand then soon died.

"That was very exciting for us," says dos Santos, "because that's exactly what we want to drive breast cancer cells to do. We want to take away their stem cell-like qualitiesespecially their ability to multiply indefinitely. We are testing the idea that a drug that inhibits BPTF might have the same effect in cancer cells as in stem cellsit could cause them to differentiate and then die."

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When studying how normal cells change into cancer cells, dos Santos and other cancer researchers pay close attention to gene expression. Every cell in the breast, including stem cells, contains the full human genome. One way of thinking about what differentiates a breast cell from a heart cell is that each cell type expresses different subsets of genes.

The same is also true within each organ. In the breast, the ducts designed to carry milk during and after pregnancy are composed of two highly specialized cell types and a niche of stem cells that gives rise to both types. Each of these different cell types expresses different groups of genes at different times over the lifespan of an individual.

As the illustration below indicates, the hollow "tube" that forms the milk duct is built from luminal cells; these are surrounded by a thin layer of cells called myoepithelial cells. Receptors on the surface of the myoepithelial cells are designed to interact with a hormone, oxytocin, released during lactation. This interaction causes the myoepithelial cellson the outer layer of the ductal structureto contract, squeezing the luminal cells within. Those luminal cells are the breast's milk factories.

BPTF's epigenetic role in exposing and hiding genes

BPTF, identified by dos Santos and colleagues as essential for mammary stem cell maintenance, is a protein with a very specialized function. It is what biologists call a chromatin remodeling factor. Chromatin is the packaging that enables six linear feet of DNA in each of our cells to be compressed inside the microscopic nucleus.

With so much DNA squished into such a small space, it stands to reason that expressing a gene in the "middle" of the bundle might require loosening the packing material to expose that segment of DNA to the machinery that copies it into an RNA molecule. This copying is the first step in using the gene's "blueprint" to manufacture a needed protein. Chemical modifications to chromatinand even more specifically, to the histone proteins that provide "spools" around which the DNA is woundare called epigenetic modifications.

"It has become very clear that the opening up or tightening of chromatin, to expose or hide genes in our chromosomes, plays a role in cancer progression," dos Santos says. "For instance, exposing a gene at a particular moment might help a cancer cell bypass a 'stop sign' in a growth pathway."

The research published today shows that BPTF is part of a regulatory system that opens chromatin and changes gene expression, specifically in mammary stem cells. This opening of the chromatin turns out to be critical in the ability of the stem cell to remain "immortal"to give rise to daughter stem cells that will also help maintain a tissue such as the breast, and seeding it, at different times of life, with specialized cells. For example, during puberty, when the breast develops, or during pregnancy, when the breast gears up to produce milk.

"We now know that mammary stem cells are highly dependent on BPTF. The next task is to explore if can we use that dependency to target stem cell-like programs in breast cancer cells," dos Santos says.

The research discussed here was supported by CSHL Cancer Center Support Grants 5P30CA045508 and 5P30CA045508-28; P01 award #2P01CA013106; the Sidney Kimmel Cancer Foundation; the Pershing Square Innovator Award; the Rita Allen Scholar Award; the V Foundation Scholar Award; and the Manhasset Coalition Against Breast Cancer Award.

"BPTF maintains chromatin accessibility and the self-renewal capacity of mammary gland stem cells" appears online June 1, 2017 in Stem Cell Reports. The authors are: Wesley D. Frey Anisha Chaudhry Priscila F. Slepicka, Adam M. Ouellette, Steven E. Kirberger, William C. K. Pomerantz, Gregory J. Hannon and Camila O. dos Santos.

Explore further: Study identifies RNA molecule that shields breast cancer stem cells from immune system

More information: "BPTF maintains chromatin accessibility and the self-renewal capacity of mammary gland stem cells" Stem Cell Reports, 2017.

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A protein that stem cells require could be a target in killing breast cancer cells - Medical Xpress

Physicist Stephen Hawking is perhaps the most famous sufferer of motor neuron disease, a crippling degenerative condition that affects an estimated 150,00 people around the world.

Karwai Tang / Getty

In news that may bring hope to Stephen Hawking and hundreds of thousands of others around the world, British scientists have used reprogrammed skin cells to study the development of motor neuron disease.

Its like changing the postcode of a house without actually moving it, explains neuroscientist Rickie Patani, referring to research offering startling new insights into the progress and treatment of the crippling degenerative condition, also known as amyotrophic lateral sclerosis (ALS).

Patani, together with colleague Sonia Gandhi, both from the Francis Crick Institute and University College London, in the UK, led a team of researchers investigating how the disease destroys the nerve cells that govern muscle movement.

The results, published in the journal Cell Reports, comprise the most fine-grained work to date on how ALS operates on a molecular level and suggest powerful new treatment methods based on stem cells.

Indeed, so exciting are the implications of the research that Ghandi and Patani are already working with pharmaceutical companies to develop their discoveries.

The neurologists uncovered two key interlinked interactions in the development of motor neuron disease, the first concerning a particular protein, and the second concerning an auxiliary nerve cell type called astrocytes.

To make their findings, the team developed stem cells from the skin of healthy volunteers and a cohort carrying a genetic mutation that leads to ALS. The stem cells were then guided into becoming motor neurons and astrocytes.

We manipulated the cells using insights from developmental biology, so that they closely resembled a specific part of the spinal cord from which motor neurons arise, says Patani.

We were able to create pure, high-quality samples of motor neurons and astrocytes which accurately represent the cells affected in patients with ALS."

The scientists then closely monitored the two sets of cells healthy and mutated to see how their functioning differed over time.

The first thing they noted was that a particular protein TDP-43 behaved differently. In the patient-derived samples TDP-43 leaked out of the cell nucleus, catalysing a damaging chain of events inside the cell and causing it to die.

The observation provided a powerful insight into the molecular mechanics of motor neuron disease.

Knowing when things go wrong inside a cell, and in what sequence, is a useful approach to define the critical molecular event in disease, says Ghandi.

One therapeutic approach to stop sick motor neurons from dying could be to prevent proteins like TDP-43 from leaving the nucleus, or try to move them back.

The second critical insight was derived from the behaviour of astrocytes, which turned out to function as a kind of nursemaid, supporting motor neuron cells when they began to lose function because of protein leakage.

During the progression of motor neuron disease, however, the astrocytes like nurses during an Ebola outbreak eventually fell ill themselves and died, hastening the death of the neurons.

To test this, the team did a type of mix and match exercise, concocting various combinations of neurons and astrocytes from healthy and diseased tissue.

They discovered that healthy astrocytes could prolong the functional life of ALS-affected motor neurons, but damaged astrocytes struggled to keep even healthy motor neurons functioning.

The research reveals both TDP-43 and astrocytes as key therapeutic targets, raising the possibility that the progress of ALS might be significantly slowed, or perhaps even halted.

Our work, along with other studies of ageing and neurodegeneration, would suggest that the cross-talk between neurons and their supporting cells is crucial in the development and progression of ALS, says Patani.

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Patients' stem cells point to potential treatments for motor | Cosmos - Cosmos

May 31, 2017 Researchers from the Institute of Bioengineering and Nanotechnology and the National Cancer Centre Singapore who discovered the approach of using patients stem cells to test for side effects of drugs. From left: Hanry Yu, Min-Han Tan and Ravindran Kanesvaran. Credit: A*STAR Institute of Bioengineering and Nanotechnology

Severe illnesses sometimes require treatment regimens carrying grave risks, including organ failure. Now, a non-invasive technique developed at A*STAR could help predict patient vulnerability to potentially toxic drugs.

Therapeutics can induce organ damage via mechanisms that vary between individuals. These idiosyncratic drug reactions are a common reason for the withdrawal of new drugs, and can be a significant problem during disease treatment.

Research led by Min-Han Tan and Hanry Yu from the Institute of Bioengineering and Nanotechnology, and National Cancer Centre shows how cells derived from a patient's blood offer the first opportunity to test an individual's susceptibility to idiosyncratic liver damage, known as hepatotoxicity; in this case, from the cancer drug, pazopanib.

Currently there is no easy way to predict idiosyncratic harm from the drug, "Pazopanib causes idiosyncratic hepatotoxicity, and liver biopsies are not commonly undertaken due to their invasive nature and potential risks," says Tan.

The researchers took white blood cells from five patients receiving pazopanib for metastatic renal cell cancer, three of whom exhibited hepatotoxicity. They converted these white blood cells into stem cells, and then into 'hepatocyte-like cells' (HLCs). This created a population of cells that retained the genetics and morphology of each patient's native liver cells, without the risks of a biopsy. The stem cells were then treated with pazopanib.

After 24 hours, the HLCs taken from the three patients exhibiting hepatotoxicity also experienced significantly more cell death than those from the two patients without liver damage. This validated that the test can model the individually-mediated effects of pazopanib on the liver.

"Currently, new drugs are tested for toxicity using generic liver cells, which cannot model patient-specific reaction. Establishing patient-specific HLCs with characteristics that are representative of genetic variation will be valuable for pharmaceutical drug testing," says Yu.

The team also discovered the mechanism by which pazopanib causes injury by evaluating the changes in HLC gene expression following drug administration. In cells from both groups of patients, gene expression changes indicated a response to drug-induced stress. HLCs from hepatotoxicity-susceptible individuals, however, also showed evidence of differential iron metabolism as well as other genetic variations from non-susceptible HLCs. This probably contributes to the greater levels of cellular damage and death and provides the first experimental evidence of pazopanib's mechanism of action in idiosyncratic hepatotoxicity.

Tan hopes his team's research could be used in future to predict an individual's response to a proposed treatment. "We plan to expand the approach to different drugs and organs, and determine the nature of drug toxicity," explains Tan. "Our ultimate goal is to benefit patients and clinicians by gaining a better understanding of toxicity."

Explore further: Toxic liver effects of fifteen drugs predicted using computational approach

More information: Yukti Choudhury et al. Patient-specific hepatocyte-like cells derived from induced pluripotent stem cells model pazopanib-mediated hepatotoxicity, Scientific Reports (2017). DOI: 10.1038/srep41238

Researchers from Monash University have developed a new drug delivery strategy able to block pain within the nerve cells, in what could be a major development of an immediate and long lasting treatment for pain.

Can a fish with a malformed jaw tell us something about hearing loss in mice and humans? The answer is yes, according to a new publication in Scientific Reports.

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Researchers at the University of Birmingham have made a breakthrough in the understanding of how our genetic make-up can impact on the activity of the immune system and our ability to fight cancer.

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Individual adverse drug responses could be predicted by a simple blood test - Medical Xpress

May 30, 2017 by Emma Mckinney Understanding our genetic make-up could be the key to beating cancer. Credit: University of Birmingham

Researchers at the University of Birmingham have made a breakthrough in the understanding of how our genetic make-up can impact on the activity of the immune system and our ability to fight cancer.

The study, conducted in conjunction with researchers from Birmingham's Queen Elizabeth Hospital, was published in Science Signaling and focusses on a protein called ULBP6.

Proteins are made up of hundreds or thousands of smaller units called amino acids, which are attached to one another in long chains. Proteins do most of the work in cells and are required for the structure, function, and regulation of the body's tissues and organs.

Lead author of the study Professor Paul Moss from the University of Birmingham's Institute of Immunology and Immunotherapy, said: "We worked on a protein called ULBP6 which leads to the removal of damaged cells and an interesting observation has been that there are two types of this protein found in different people.

"This is important as previous studies have shown that the type of protein that we inherit from our parents can influence our risk of auto-immune disease and affect how we respond to some forms of cancer treatment.

"The ULBP6 protein is found on the surface of damaged cells, including several types of cancer cells, and acts as a 'flag' to signal to white cells in our immune system that the damaged cell should be killed.

"Interestingly, there are two major types of this protein in the population and people who inherit a certain subtype have been shown to have a poor outcome after stem cell transplantation, a procedure used to treat leukaemia, which is commonly referred to as 'bone marrow treatment'."

Professor Ben Willcox, also from the University of Birmingham's Institute of Immunology and Immunotherapy, said: "The two types of ULBP6 differ only by two amino acids out of a total of around 180 and it has surprised us that this can have such an important influence on patient outcomes.

"In the study we found that one form of ULBP6 forms a very strong bond indeed with its receptor NKG2D on the immune system. In addition, when the protein is released into the local environment it can act to block the signalling pathway.

"The 'sticky' form of ULBP6 binds over 10 times more strongly to NKG2D but a major surprise was that this acted to reduce killing by the immune system rather than increase it. We now want to understand how this information might be used to improve the outcome of patients undergoing stem cell transplantation."

The study was funded by the Bloodwise and the Wellcome Trust. Bloodwise, the UK's specialist blood cancer charity, funds world-class research and offers expert information and support to anyone affected by leukaemia, lymphoma, myeloma and other blood cancer related disorders.

Alasdair Rankin, Director of Research at Bloodwise, said: "For some people with leukaemia and other types of blood cancer, stem cell transplantation can mean the difference between life and death. But a stem cell transplant is a gruelling procedure which sadly does not always work, so we need research to improve success rates.

"This research will not change care today, but it helps us understand why transplants work less well in some people, which is an important step on the path to developing better transplant therapy for more people living with blood cancer."

Wellcome Trust is a global charitable foundation, supporting scientists and researchers to take on big problems, fuel imaginations, and spark debate.

Explore further: Study leads to breakthrough in better understanding acute myeloid leukemia

More information: A disease-linked ULBP6 polymorphism inhibits NKG2D-mediated target cell killing by enhancing the stability of NKG2D-ligand binding. Science Signaling, DOI: 10.1126/scisignal.aai8904

A study led by the University of Birmingham has made a breakthrough in the understanding of how different genetic mutations cause acute myeloid leukaemia.

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Researchers at the University of Birmingham have made a breakthrough in the understanding of how our genetic make-up can impact on the activity of the immune system and our ability to fight cancer.

One area of research within mechanobiology, the study of how physical forces influence biological processes, is on the interplay between cells and their environment and how it impacts their ability to grow and spread.

Diabetic patients frequently have lesions on their feet that are very difficult to heal due to poor blood circulation. In cases of serious non-healing infections, a decision to amputate could be made. A new therapeutic approach, ...

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Home / News / Ottawa Hospital Stem Cell Discovery 'A... http://www.ottawacommunitynews.com/ A new stem cell treatment is in development at the hospital, which has the potential to heal the damaged lungs of premature babies, like Olivia. - Erin McCracken/ ... The research team originally thought these would replace the dead lung cells. But ...

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Joanne Schnurr, CTV Ottawa Published Thursday, May 25, 2017 3:33PM EDT Last Updated Thursday, May 25, 2017 6:55PM EDT

An Ottawa doctor and scientist has been awarded more than half a million dollars for ground-breaking research into using umbilical stem cells to fight chronic lung disease in premature babies.

It is research that Dr. Bernard Thbaud calls a game-changer. Right now, Dr. Thbauds work is in the early stages but there are indications that this could dramatically help the outcome for babies who are born weeks before they are due. And, the protective power of these stem cells may have multiple applications.

May 24th is the day that Olivia Eberts should have been born. But she and her twin brother Liam decided to come into the world 115 days early at just 23 weeks and 4 days gestation.

Liam passed away at 3 weeks, says his mother, Jamie Eberts, He unfortunately didn't make it; he was much sicker than Olivia.

Olivia has had her struggles, too. Born at just over one pound, she's had heart surgery, kidney problems and lung problems from the artificial help to keep her tiny lungs working.

Theres a lot of issues that come along with being born as young as they are, says Jamie, and it's going to be a lifelong battle for her and we don't know what the future will bring.

Dr. Bernard Thbaud is working on that future. Dr. Thbaud, a neonatologist and senior scientist at The Ottawa Hospital and CHEO, and professor at the University of Ottawa, is doing research into the possibility of using stem cells from the umbilical cord to combat lung disease in premature babies.

What we see in lab is very promising, he says, We think this will be a game changer, because the way these cells act is like something we have never seen before.

Right now, 40% of all premature babies have a lung disease called bronchopulmonary dysplasia or BPD. It can cause a lifetime of problems, even death. And there is no treatment. With funds from the Ontario Institute for Regenerative Medicine, Dr. Thbaud hopes to find a treatment using these miracle stem cells.

We have harnessed the healing potential of stem cells that we can take out of the umbilical cord, Dr. Thbaud adds.

Thbaud is also examining the impact these stem cells can have on septic shock in premature babies and their potential for helping with brain functioning in the babies.

We think these cells will improve the overall outcome of these pre-term babies. Now we have to make sure this is happening in a proper way and allow them to fulfill their promise.

Treatment would have to start, about a week after birth. So while Olivia may not benefit, her parents are still on board with the research

Tim Eberts is her father, The thought that other kids that will come through here could be helped by it, that's encouraging for us and we'd like to be involved in it.

Olivia is getting stronger. She now weighs 6 and a half pounds but will still be in hospital for a while yet.

Dr. Thbaud hopes to start his clinical trials in two years time.

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A potential game-changer to battle lung disease in premature babies. - CTV News

You are here: Home News Industry news FDA approves first cancer treatment for any solid tumor with a specific biomarker

The US Food and Drug Administration (FDA) granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumour originated.

Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumours that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This indication covers patients with solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.

This is an important first for the cancer community,

said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDAs Center for Drug Evaluation and Research and director of the FDAs Oncology Center of Excellence. Until now, the FDA has approved cancer treatments based on where in the body the cancer startedfor example, lung or breast cancers. We have now approved a drug based on a tumours biomarker without regard to the tumors original location.

MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumours with these biomarkers are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland and other places. Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumours.

Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the bodys immune cells and some cancer cells). By blocking this pathway, Keytruda may help the bodys immune system fight the cancer cells. The FDA previously approved Keytruda for the treatment of certain patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

Keytruda was approved for this new indication using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe anticipated clinical benefits of Keytruda, and the sponsor is currently conducting these studies in additional patients with MSI-H or dMMR tumours.

The safety and efficacy of Keytruda for this indication were studied in patients with MSI-H or dMMR solid tumours enrolled in one of five uncontrolled, single-arm clinical trials. In some trials, patients were required to have MSI-H or dMMR cancers, while in other trials, a subgroup of patients were identified as having MSI-H or dMMR cancers by testing tumour samples after treatment began. A total of 15 cancer types were identified among 149 patients enrolled across these five clinical trials.

The most common cancers were colorectal, endometrial and other gastrointestinal cancers. The review of Keytruda for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response). Of the 149 patients who received Keytruda in the trials, 39.6% had a complete or partial response. For 78% of those patients, the response lasted for six months or more.

Common side effects of Keytruda include fatigue, itchy skin (pruritus), diarrhea, decreased appetite, rash, fever (pyrexia), cough, difficulty breathing (dyspnea), musculoskeletal pain, constipation and nausea. Keytruda can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis). Complications or death related to allogeneic hematopoietic stem cell transplantation after using Keytruda has occurred.

The FDA granted this application Priority Review designation, under which the FDAs goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

The FDA granted accelerated approval of Keytruda to Merck & Co.

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FDA approves first cancer treatment for any solid tumor with a specific biomarker - European Pharmaceutical Review

FitzGerald, Susan

doi: 10.1097/01.NT.0000520472.01901.8f

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Two new reports on autologous hematopoietic stem cell transplantation (AHSCT) for multiple sclerosis (MS) indicate that the therapy may benefit some MS patients. But whether AHSCT is viable is a matter of debate among some MS experts, who contend that the regimen could be toxic, leading to infection and death.

Two new reports on autologous hematopoietic stem cell transplantation (AHSCT) for multiple sclerosis (MS) indicate that the therapy may benefit some MS patients. But whether AHSCT is viable is a matter of debate among some MS experts, who contend that the regimen, which uses a combination of cytotoxic drugs to ablate the immune system in an attempt to reset the immunological memory could be toxic, leading to infection and death.

Experts who were not involved with the study said that newer, second generation MS drugs may be safer options, though few studies comparing the method with these drugs have been undertaken.

The first new report, published in the April 28 online edition of Neurology, provided a meta-analysis of 15 studies involving 764 MS patients who underwent AHSCT. The report found that the risk-benefit profile of the therapy makes it best suited for patients who have aggressive, relapsing-remitting MS who have not yet become highly disabled.

The second report, which provided long-term outcomes for 281 MS patients from an observational, retrospective study, found that almost half of the patients remained free from neurological progression five years after AHSCT. The study, published in the April edition of JAMA Neurology, reported that younger age, relapsing form of MS, fewer prior immunotherapies, and lower baseline EDSS [Expanded Disability Status Scale] score were factors associated with better outcomes.

Maria Pia Sormani, PhD, professor of biostatistics at the University of Genoa in Italy, and lead author of the report in Neurology, told Neurology Today that skepticism about the treatment approach is likely due to multiple factors.

MS is not a lethal disease, and this procedure is very invasive and has a non-negligible mortality risk, said Dr. Sormani, who also was a study author on the JAMA Neurology study. The lack of data from a rigorous clinical trial of AHSCT for MS has also been problematic.

To gain a clearer picture of what the current evidence shows, her team's meta-analysis pooled data from 15 studies, mostly open label, from January 1991 to July 2016. The researchers found that treatment-related mortality (TRM) declined during the period covered by the review, likely a result of improvements in transplant techniques, more clinical experience, and better patient selection, Dr. Sormani said. Overall TRM was 2.1 percent, but after 2005 it was 0.3 percent.

The meta-analysis found that the rate of disease progression in patients was 17.1 percent at two years following AHSCT and 23.3 percent at five years. The analysis also found that 83 percent of patients had no evidence of disease activity (NEDA) at two years, and 67 percent had no evidence at five years. Doing the transplant earlier, before the patient develops much disability seems advantageous, Dr. Sormani said.

The meta-analysis had the usual limitations of such reviews, she noted. The original studies were not all designed or executed in the same way, patient selection and study methodology were not uniform, and transplant techniques and protocols varied.

Even with advanced immunotherapy, such as natalizumab or alemtuzumab, only 32-39 percent maintained NEDA at two years in the phase II clinical trials, wrote Joachim Burman, MD, PhD, of Uppsala University in Sweden and Robert Fox, MD, of the Cleveland Clinic, in the editorial accompanying the paper. They agreed with the research team that the approach is more likely to benefit those with RRMS, not those with progressive forms of MS.

The report in JAMA Neurology included data on 281 patients from 25 centers who underwent AHSCT between January 1995 and December 2006. Seventy-eight percent of the patients had progressive forms of MS. The median follow-up was 6.6 years, with some patients followed for as long as 16 years

The five-year probability of progression-free survival was 46 percent and overall survival was 96 percent, the research team headed by Paolo A. Muraro, MD, a clinical reader in neuroimmunology and deputy head of the division of brain sciences at Imperial College London.

Factors associated with neurological progression after transplant were older age, progressive (versus relapsing) form of MS, more than two previous disease-modifying therapies, and higher baseline EDSS scores.

An accompanying editorial coauthored by Michael K. Racke, MD, professor of neurology and neuroscience at Ohio State University, noted that while the transplant therapy appears to favor those with RRMS with aggressive breakthrough disease, it Z

Dr. Racke told Neurology Today in an interview that he is currently planning a multicenter randomized controlled trial, which will include 55 RRMS patients in each arm. The study will compare AHSCT using what is considered a medium-intensity myelobation (BEAM) technique to best available drug treatment (whatever treatment a given patent is taking).

Dr. Racke said one question that needs to be further considered is, When is the best time to do a transplant? He said drug therapies need to be given a chance, but earlier might be better than later because once you start getting damage to the central nervous system we can't really fix that.

He said the upcoming trial will likely include cost analyses to compare the cost of long-term drug therapy to the mostly upfront costs of transplant, which is thought to be a once-and-done procedure.

Commenting on the two studies, Timothy L. Vollmer, MD, FAAN, professor of neurology at University of Colorado Health Sciences Center and co-director of the Rocky Mountain MS Clinic at Anschutz Medical Center, expressed skepticism about using AHSCT, particularly in light of effectiveness of the second-generation MS drugs that have come into use, such as natalizumab for JCV negative patients, fingolimod, dimethyl fumarate, and ocrelizumab.

Dr. Vollmer said most studies of AHSCT for MS were done before the newer drugs were available. He is concerned about both the immediate risks (infection, death) and potential long-term consequences of undergoing a toxic regimen to eradicate the immune system, noting that it could cause brain atrophy, already a concern for MS patients.

Mark S. Freedman, MD, professor of neurology at the University of Ottawa, senior scientist at The Ottawa Hospital Research Institute, and director of the Multiple Sclerosis Research Unit at The Ottawa Hospital-General Campus, is more sanguine about the procedure.

In a 2016 report in The Lancet, he and a colleague described outcomes for 24 RRMS patients who underwent transplant after failing drug therapy. Dr. Freedman said he has done about 25 more cases since the study came out. He said no patient has experienced a clinical relapse following transplant, none has evidence of new brain lesions on MRI, and none requires disease-modifying medication.

Dr. Freedman said there is a high level of interest in the procedure among MS patients, but it isn't for everyone. Patients must be carefully selected for the procedure, and undergo an aggressive chemotherapy regimen to eliminate their immune system, he said, noting that those with a high inflammatory component to their disease are ideal. Harvested stem cells undergo a special sorting technique at his center before being infused into the body to make sure that no previous disease-causing lymphocytes are accidentally included.

We're taking away immunologic memory, Dr. Freedman said. The new immune system is learning all over again what it should and shouldn't be doing.

He said that while the procedure is only done in patients who have not fared well with drug therapy, the best timing for this treatment would be as early as possible, when disability is minimal.

Probably doing it within five years from the onset of illness would give the optimal results, he said.

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Is Autologous Hematopoietic Stem Cell Transplantation Still Viable for MS? - LWW Journals

After decades of practising conventional, high-tech, hospital-based medicine, I experienced a profound shift in my understanding of health and healing. I realised that healing was an internal process that the body itself performed. The human body was designed with a tremendous capacity to heal itself. I, the doctor, was not really the healer.

My job with my medicines, surgery and other techniques was to support and encourage the healing process, to create the optimal circumstances for repair and healing to take place. Yes, my treatments could help correct a negative situation, restore balance and even save a life, but ultimately, the body could heal itself.

The human body is composed of up to 100 trillion microscopic units called cells. These cells are the building blocks of life. Each cell is intelligent and sophisticated, cooperating with its fellows to maintain the body's health.

Normally, cells are not immortal and as they age, get damaged or diseased, they die and are replaced. For example, liver and skin cells have a three-month lifespan; red blood cells live for four months; while the cells lining your intestines are quickly replaced every two days.

Every minute, millions of your body's cells die and new ones take their place. Each year, over 90 per cent of your cells are replaced as the body continually repairs itself. Old medical dogma had insisted that once brain cells died they could not be replaced. We now know that even the brain can regenerate new cells.

Heart specialists had also claimed that when heart cells die from a heart attack, they never grow back. Not true. Groundbreaking research has overturned the old, negative thinking, showing that heart cells are capable of regenerating themselves. This is great news, as heart attacks that damage hearts and strokes that injure brains are two of the commonest causes of death and disability worldwide. Old beliefs die hard, and years may pass before most doctors come to accept these new discoveries.

The body repairs itself using special cells called stem cells. A stem cell is a cell produced in the body with the ability to create all types of new cells. Your body creates these stem cells every day and they act as a repair system, replenishing damaged tissues. Modern medicine is racing to find expensive ways to transplant stem cells into patients to promote healing. This has been called regenerative medicine. An example of this approach is the injection of stem cells into the hearts of people with severe heart disease. The world welcomes all the help modern, sophisticated medicine offers.

However, my focus is on natural regenerative medicine: how to encourage your body to produce more of its own stem cells for your healing. Then, if that fails, we can consider the more dangerous, expensive and invasive options. Research has shown that your lifestyle influences the activation of these stem cells and may improve the ability of your body to self-repair and heal.

New research reveals that the body increases stem cell numbers when we exercise. The more active we are, the more new cells we need and the more stem cells we make. Physical exercise not only stimulates an increase of stem cells in your muscles, but also in other tissues such as heart, bone, brain, liver, etc.

Researchers in China report that people who practise the martial art tai chi saw a significant boost in their stem cell populations. I suspect the same may be true of yoga.

Regular exercise not only prevents disease, but also keeps stored stem cells in reserve for healing after stress and injury. Although exercise can boost stem cell numbers, optimal stem cell activity is enhanced when exercise is accompanied with healthy sleep and good stress management.

Research shows that fasting boosts stem cell production. Even after a few days of fasting, the number of stem cells in the blood is definitely elevated. It seems that the body becomes more efficient when food intake is lowered and boosts its stem cell output. Meals low in calories but high in nutrient value are ideal for this purpose. The quality of your nutrition has a major impact on the quality of your cells. The cellular nutrition meal-replacement shake and supplements are great tools for that purpose.

Research conducted at the University of Pennsylvania medical school revealed that a type of oxygen therapy using hyperbaric oxygen dramatically increases stem cell activity. The results were amazing. After only one treatment, concentrations of stem cells doubled, and after a full course of 20 treatments, stem cell levels increases by 800 per cent!

Our neighbours, the Cubans, have long promoted and successfully used hyperbaric oxygen to help in the recovery from strokes and other nervous system and circulatory problems. Other simpler and still useful oxygen therapies include ozone therapy, breathing oxygen while exercising, and even some deep-breathing techniques.

We live in a toxic world. For example, the plastic industry has filled our lives with products made of or stored in plastic. There is growing evidence that some of the chemicals in plastics such as bisphenol-A and polyvinyl chloride are dangerous and may damage stem cells. Regular detoxification of the body is therefore very important for good health.

To be really safe, try to limit storing food in plastic containers, or drinking out of plastic bottles. Also, never microwave food in a plastic container of any kind, even if it says it is microwave-safe. In general, use microwave ovens as little as possible.

Based on current evidence, popularly advertised stem cell enhancement supplements are not effective. Stem cell experts say they are at best a waste of money and at worst a risk to your health.

- You may email Dr Vendryes at tonyvendryes@gmail.com or listen to 'An Ounce of Prevention' on POWER 106 FM on Fridays at 9 p.m. Visit http://www.tonyvendryes.com for details on his books and articles.

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Ounce of Prevention | The wonder of natural regenerative medicine - Jamaica Gleaner

Alimorad Farshchian, M.D., founder and medical director of The Center for Regenerative Medicine, founded in 1999.

A Miami doctor who has developed an international reputation for medical innovation over the last 18 years has become a pioneer in the burgeoning and critically important field of stem cell therapy.

Alimorad Farshchian, M.D., founder and medical director of The Center for Regenerative Medicine, founded in 1999, has developed innovative, safe and effective stem cell treatments for Parkinsons Disease, spinal stenosis and other physical ailments, such as back and knee problems. More recently, he has developed stem cell-derived eye drops that have successfully treated a range of eye disorders, including retinitis pigmentosa.

Since 2006, Dr. Farshchian has treated more than 11,000 patients in more than 50countries with his proprietary stem cell therapies. Despite his major innovation and success with stem cell therapies, he is best-known worldwide for successfully treating the late Michael Jackson for his addiction to prescription painkillers and also for an ankle injury before what would have been the new tour Jackson planned before his death.

Stem cells are the bodys most fundamental raw materials the cells from which all other cells with specialized functions are generated. They either become new stem cells or specialized cells, such as retina cells for the eyes. No other cell in the human body has the ability to generate new types of cells that address specific bodily functions.

Beginning in 1999, Dr. Farshchian, a member of the American Academy ofAnti-Aging Medicine, began a quest to develop new and more effective treatments forneurodegenerative diseases such as Parkinsons Disease. In 2006, he began experimenting with revolutionary stem cell treatments that involve using the patients own stem cells, known as autologous stem cells, which are reinjected into the patients body after minimal processing.

Ive experienced great improvement as a result of the stem cell treatments, says 62-year-old Sharon Davis of Cocoa, Florida, who was diagnosed with Parkinsons Disease three and a half years ago. After taking medications for more than three years that did not eliminate her symptoms and also had unpleasant side effects, she sought out Dr. Farshchian after he successfully treated her 37-year-old daughter, Heather Fleckinger, who had suffered from chronic and severe lower back problems for five years.

A series of three monthly stem cell injections significantly relieved Ms. Daviss symptoms, especially the shaking she was experiencing on her right side, and reduced her need for prescription medications. Based on how much he helped me, I tell everybody I know to go see him, says Ms. Davis, who is continuing treatment in the hope her symptoms will be completely alleviated, ending her need for any medications.

Her daughter, Ms. Fleckinger, says, I feel like Dr. Farshchian saved my life. Before I went to see him, I wore a back brace and took daily medications, but my back problems still prevented me from doing my job as a horse trainer and I had to wear a back brace almost constantly. Over a five-year period, I also tried chiropractors and acupuncture, but nothing worked.

Then, she says, a series of three stem cell injections from Dr. Farshchian over a one-week period cured her. Within three weeks, my back felt much better, she says. And after four weeks, it didnt hurt at all. I could hardly believe it. I consider it a miracle. She returns for follow-up booster shots every six to 12 months.

Rose Rubino, a 69-year-old business owner from Cape Canaveral, has been treated with Dr. Farshchians stem cell therapies over the last seven years for knee problems, severe arthritis, and spinal stenosis.

The first time I went to see him, I was scheduled for knee replacement surgery,Ms. Rubino says. But I ended up being able to avoid surgery because of the incredible resultI got from the stem cell injections. She received three injections over a one-week period.

Three months later, her 54-year-old sister suffered a frozen shoulder. Doctors told herthe condition required arthroscopic surgery. Instead, based on Ms. Rubinos recommendation, she saw Dr. Farshchian, who treated her successfully with a single stem cell injection. So shewas able to avoid surgery, just like I was, Ms. Rubino says.

Over the past five years, Dr. Farshchian has also successfully treated Ms. Rubino for arthritis and spinal stenosis. Dr. Farshchian saved my life, as far as Im concerned, she says. Nobody ever told me that as I aged, I would develop all these painful physical ailments that would supposedly require surgery. And every time, Dr. Farshchians stem cell treatments worked. I consider myself his unofficial spokesperson, because as far as Im concerned he performed multiple miracles in my life. So I tell the world about him, every chance I get.

Dr. Farshchians latest progress is in the field of optical regeneration. He has developed proprietary eye drops, trademarked as iFarshchian Drops, to treat retinitis pigmentosa, a genetic disorder that involves a breakdown and loss of cells in the retina.

The drops are uniquely developed for each patient from his or her own stem cells and are engineered to penetrate the sclera, or white outer layer of the eyeball, in order to find damaged eye cells and rejuvenate them.

Dr. Farshchian stresses that recently reported and serious complications from therapy at a South Florida clinic that injected stem cells into the eyes of patients were the result of flawed delivery of the therapy, rather than the therapy itself, which has been proven safe and successful in ongoing clinical trials at University of California at Irvine and at RIKEN Laboratory in Kobe, Japan. He also emphasizes that his eye drops are less invasive and safer than injections.

This spring, Dr. Farshchians eye drops successfully treated 89-year-old James

Enochs of Prince George, VA for degenerative eye disease. Ive already had significant improvement in my ability to read an eye chart, says Enochs, who was successfully treated with stem cell therapy by Dr. Farshchian for chronic knee problems seven years ago. My eyes had been very sensitive to wind and light. And Ive noticed a significant improvement in that sensitivity. I can only speak about the eye drops from my own experience. But for me,they have already delivered pretty remarkable results. He will now continue to use the dropsat home.Dr. Farshchian is a very brilliant and innovative doctor, Enochs says. I was justabout as skeptical as you could be the first time I came to Miami seven years ago fortreatment on my knees. But I had a huge success with my knees, and was able to avoid thesurgery that my orthopedist wanted to perform. Now Ive also had success with my eyes.So Im very impressed with his work with stem cells. Im not a skeptic anymore. Because Dr. Farshchian uses only autologous stem cells those taken from a patients own body the therapies are neither restricted nor regulated by the Food & Drug Administration. But, Dr. Farshchian points out, he fully complies with all stem cell-related FDA recommendations.

The three primary disorders that I treat with stem cells retinitis pigmentosa, Parkinsons Disease, and spinal stenosis, are difficult to treat traditionally because they are stubbornly resistant to surgery, Dr. Farshchian says. That means that most patients with those conditions are in dire need of a new alternative that works. And very few of them are aware yet of the dramatic breakthroughs being made with stem cell therapies.

His stem cell treatments are not Dr. Farshchians first major medical innovation. Almost 20 years ago, he coined the term orthopedic regenerative medicine to describe the highly effective new treatments he developed for common ailments such as arthritis.

The Center for Regenerative Medicine is located at 1001 NE 125th Street in North Miami. For more information , call (305) 891-4686 or visit ArthritisUSA.net.

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Miami Doctor Pioneers Innovative Stem Cell Therapies For Parkinson's Disease, Spinal Stenosis And Degenerative ... - Miami's Community Newspapers