Editor's NOTE:
Apart from the fact that embryonic stem cell research (ESCR) is immoral, the testing on humans in this case would appear to be premature in that no testing has been done to date on primates. The documented creation of malignant tumors in animals is extremely worrisome and the possibility of tumor creation in primates should have been studied before subjecting humans to testing.
--Dr. J. Hubert
First tests for stem cell therapy are near
By Rob Stein
Washington Post
Sunday, August 29, 2010; 6:14 PM
Even as supporters of human embryonic stem cell research are reeling from last week's sudden cutoff of federal funding, another portentous landmark is quietly approaching: the world's first attempt to carefully test the cells in people.
Scientists are poised to inject cells created from embryonic stem cells into some patients with a progressive form of blindness and others with devastating spinal cord injuries. That's a welcome step for researchers eager to move from the laboratory to the clinic and for patients hoping for cures. But beyond being loathsome to those with moral objections to any research using cells from human embryos, the tests are worrying many proponents: Some argue that the experiments are premature, others question whether they are ethical, and many fear that the trials risk disaster for the field if anything goes awry.
"We desperately need to know how these cells are going to perform in the human setting," said John Gearhart, a stem cell pioneer at the University of Pennsylvania. "But are we transplanting cells that are going to cause tumors? Will they stay where you put them and do what you want them to do?"
Supporters of these privately funded, government-sanctioned tests, including patients' advocates, bioethicists and officials at the companies sponsoring them, are confident that research has been exhaustively vetted. The Food and Drug Administration has demanded extensive experiments in the laboratory and on animals to provide evidence that the cells are safe enough to test in people and hold great promise.
"We're very optimistic," said Thomas B. Okarma, president and chief executive of Geron Corp. of Menlo Park, Calif., which after years of delay received a green light in July from the FDA to study patients partially paralyzed by spinal cord injuries. "If we're right, we'll revolutionize the treatment of many chronic diseases."
But some researchers fear that the stakes jumped even higher with the federal judge's decision blocking federal funding. If patients are hurt by the cells - or even if there's no hint the cells help - that could be a devastating blow just as scientists are scrambling for funding from private foundations and benefactors. They cite the case of Jesse Gelsinger, whose 1999 death from a gene therapy experiment set that once highly touted field back years.
"There's a lot of angst around these trials," said Evan Y. Snyder, director of the stem cell program at the Sanford-Burnham Medical Research Institute in San Diego. "There's going to be this perception that if the cells do not perform well, the entire field will be illegitimate."
Most of the apprehension focuses on the Geron trial. Safety worries - most prominently fears that the cells could cause tumors - prompted the FDA to repeatedly demand additional data from Geron, including most recently assurance cysts that developed in mice injected with the cells posed no threat.
"We jumped through a lot of hoops to convince a lot of audiences," Okarma said. No one wants another Jesse Gelsinger."
While Geron eventually hopes to test the cells on many patients the first trial will involve 10 partially paralyzed by a spinal cord injury in the previous one to two weeks. Surgeons will inject the first patient with about 2 million "oligodendrocyte progenitor cells," created from embryonic stem cells, in the hopes the cells will form a restorative coating around the damaged spinal cord. In tests in hundreds of rats, partially paralyzed animals walked.
The trial is designed primarily to ensure the cells are safe. But researchers will look for signs that the therapy restores sensation or enables patients to regain movement.
"If we were able to do that, it would be a phenomenally positive result," Okarma said. MORE...
____________
Editor's NOTE:
Here is the follow-on piece.
Dr. J. Hubert
First patient treated in stem cell study
By Rob Stein
Washington Post
October 11, 2010; 9:06 AM ET
The first patient has been treated with human embryonic stem cells in the first study authorized by the Food and Drug Administration to test the controversial therapy.
A patient who was partially paralyzed by a spinal cord injury had millions of embryonic stem cells injected into the site of the damage, according to an announcement early Monday by the Geron Corp. of Menlo Park, Calif., which is sponsoring the groundbreaking study.
The patient was treated at the Shepherd Center, a 132-bed hospital in Atlanta that specializes in spinal cord and brain injuries, Geron said. The hospital is one of seven sites participating in the study, which is primarily aimed at testing whether the therapy is safe. Doctors will, however, also conduct a series of specially designed tests to see whether the treatment helps the patients. No additional information about the first patient was released.
With U.S. stem cell treatments limited, some patients have tried other countries. Experimental stem cell treatments offered in China are luring American patients such as 9-year-old Kara Anderson, whose parents took her around the world to help treat her cerebral palsy.
The study marks a milestone in stem cell research, which is considered one of the most promising developments in medical research in decades but has been fraught with controversy.
The announcement comes as the future of federal funding for embryonic stem cell research remains in doubt. A federal judge ruled in August that the Obama administration's more permissive policy for funding the research violated a federal law prohibiting taxpayer money being used for research that involves the destruction of human embryos. The Justice Department is appealing.
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Monday, October 11, 2010
Sunday, March 8, 2009
FDA Approves Embryonic Stem Cell Research Trials on Humans Despite Concerns
by Steven Ertelt
LifeNews.com Editor
January 23, 2009
Washington, DC (LifeNews.com) -- Despite grave concerns that problems such as the causing of tumors and immune system rejection issues haven't been solved, the FDA has approved the use of embryonic stem cells for human trial. Embryonic stem cell research has never cured or helped any patients to this point.
Only the use of adult stem cells and treatments derived from them have cured or reduced the effects of any diseases or conditions afflicting patients.
That efficacy reason, combined with the fact that embryonic stem cells can only be obtained by destroying early human life, has prompted the pro-life movement to oppose their use.
But now, the Food and Drug Administration has given biotechnology company Geron Corp., based in California, permission to conduct the first-ever human trial for a treatment derived from the controversial cells.
The trial will involve 10 spinal cord patients with injuries the company hopes to treat with an experimental drug containing embryonic stem cells.
"This is the dawn of a new era in medical therapeutics," Thomas B. Okarma, Geron's president and chief executive officer, told the Wall St. Journal. "The hope that stem-cell therapy will repair and regenerate diseased organs and tissue goes beyond what pills and scalpels can ever do."
The timing of the announcement appears suspicious to some pro-life advocates who note that Obama campaigned on a pledge to overturn the funding limits President Bush put in place.
Bush limited spending on embryonic stem cells to existing cells and would not fund the destruction of more human lives to advance science. Instead, he spent hundreds of millions on adult stem cells because of these ethical concerns and because they were the only cells to help patients.
Karen Riley, an FDA spokeswoman, denied that politics had anything to do with the timing of the decision.
"The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," she told the Journal. "Political considerations have no role in this process."
Though the FDA approved the trial, that doesn't mean the political battle over embryonic stem cell research funding is over.
President Obama will either have to issue an executive order to overturn the Bush protections from making taxpayers fund life-destroying research or he will have to rely on Congress to do so -- which seems more likely.
In a recent interview with CNN, he indicated he may rely on Congress to overturn the limits.
"I like the idea of the American people's representatives expressing their views on an issue like this," he said.
However, the reason may be more political in nature as a Congressional bill would have the force of law and be harder for a pro-life president to overturn, as legislation would be needed to reverse the decision.
Approval of the study is no guarantee that the treatment will work or that drugs based off of it will enter the market and be available to patients on a national basis.
That's in part because embryonic stem cell researchers have yet to overcome all of the problems that have plagued the drug in use with animals.
The cells have had two main scientific problems in that they tend to cause tumors after they are injected and the body's immune system rejects the foreign cells. These problems are not seen in use with adult stem cells.
The patients in the trial will be ones who can receive treatment within 14 days after a spinal cord injury has left them paralyzed. They will need to be followed for a year to determine if the treatments had any effect.
LifeNews.com Editor
January 23, 2009
Washington, DC (LifeNews.com) -- Despite grave concerns that problems such as the causing of tumors and immune system rejection issues haven't been solved, the FDA has approved the use of embryonic stem cells for human trial. Embryonic stem cell research has never cured or helped any patients to this point.
Only the use of adult stem cells and treatments derived from them have cured or reduced the effects of any diseases or conditions afflicting patients.
That efficacy reason, combined with the fact that embryonic stem cells can only be obtained by destroying early human life, has prompted the pro-life movement to oppose their use.
But now, the Food and Drug Administration has given biotechnology company Geron Corp., based in California, permission to conduct the first-ever human trial for a treatment derived from the controversial cells.
The trial will involve 10 spinal cord patients with injuries the company hopes to treat with an experimental drug containing embryonic stem cells.
"This is the dawn of a new era in medical therapeutics," Thomas B. Okarma, Geron's president and chief executive officer, told the Wall St. Journal. "The hope that stem-cell therapy will repair and regenerate diseased organs and tissue goes beyond what pills and scalpels can ever do."
The timing of the announcement appears suspicious to some pro-life advocates who note that Obama campaigned on a pledge to overturn the funding limits President Bush put in place.
Bush limited spending on embryonic stem cells to existing cells and would not fund the destruction of more human lives to advance science. Instead, he spent hundreds of millions on adult stem cells because of these ethical concerns and because they were the only cells to help patients.
Karen Riley, an FDA spokeswoman, denied that politics had anything to do with the timing of the decision.
"The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," she told the Journal. "Political considerations have no role in this process."
Though the FDA approved the trial, that doesn't mean the political battle over embryonic stem cell research funding is over.
President Obama will either have to issue an executive order to overturn the Bush protections from making taxpayers fund life-destroying research or he will have to rely on Congress to do so -- which seems more likely.
In a recent interview with CNN, he indicated he may rely on Congress to overturn the limits.
"I like the idea of the American people's representatives expressing their views on an issue like this," he said.
However, the reason may be more political in nature as a Congressional bill would have the force of law and be harder for a pro-life president to overturn, as legislation would be needed to reverse the decision.
Approval of the study is no guarantee that the treatment will work or that drugs based off of it will enter the market and be available to patients on a national basis.
That's in part because embryonic stem cell researchers have yet to overcome all of the problems that have plagued the drug in use with animals.
The cells have had two main scientific problems in that they tend to cause tumors after they are injected and the body's immune system rejects the foreign cells. These problems are not seen in use with adult stem cells.
The patients in the trial will be ones who can receive treatment within 14 days after a spinal cord injury has left them paralyzed. They will need to be followed for a year to determine if the treatments had any effect.
World's First Embryonic Stem Cell Study In Humans
Editor's NOTE:
Apropos the pending Obama administration announcement which will purportedly legalize federal funding for embryonic stem cell research is the following ESCR trial to be conducted at UC Irvine in humans.
To date, there have been no successful ESC treatment applications in humans. Complications have included destructive tumor formation (teratomas) and problems relating to systemic immunity. As is well-known, there have been myriads of successful clinical applications/treatments utilizing adult stem cells and those procured from fetal cord blood.
--Dr. J. P. Hubert
Article Date: 26 Jan 2009 - 0:00 PSTA
Medical News Today
A therapy developed at UC Irvine that made paralyzed rats walk again will become the world's first embryonic stem cell treatment tested in humans.
The U.S. Food and Drug Administration has approved the therapy, based on work by a research team led by Hans Keirstead, co-director of the UCI Sue and Bill Gross Stem Cell Research Center, for a clinical trial in patients with acute spinal cord injury.
Geron Corp. of Menlo Park, Calif., will conduct the clinical trial.
"This trial was approved only after rigorous safety testing and consultation of countless experts in the field," Keirstead said. "Any benefit to the patient, even an incremental one, would be a resounding victory."
The therapy contains human embryonic stem cells destined to become spinal cord cells called oligodendrocytes. These are the building blocks of myelin, the biological insulation for nerve fibers that is critical for maintaining electrical conduction in the central nervous system. When myelin is stripped away, through injury or disease, paralysis can occur.
In laboratory tests, Keirstead and his colleague, Dr. Gabriel Nistor, developed a technique for prompting human embryonic stem cells to develop into oligodendrocyte cells.
Injected into rats with spinal cord injuries, the precursor cells turned into oligodendrocytes and migrated to the injured area of the spinal cord. As the cells wrapped around damaged neurons, new myelin tissue formed, allowing electrical conduction to resume and the rats to walk again.
This success, published in the Journal of Neuroscience in 2005, was the subject of dozens of media stories, including a "60 Minutes" segment.
According to Geron, patients eligible for the phase-one trial must have a certain type of spinal cord damage and be willing to receive injections 7-14 days after injury. Geron has selected up to seven U.S. medical centers that may participate in the study.
UCI has a robust stem cell research program that has received more than $52 million from the California Institute for Regenerative Medicine. UCI's scientists are pioneers in regeneration, large-scale production of specialized cells with very high purity, and methods for treating damaged tissues.
UCI recently broke ground for a four-story building dedicated to stem cell research. When finished in 2010, the building will house the stem cell center, dozens of laboratory-based and clinical researchers, a stem cell techniques course, a master's program in biotechnology with an emphasis on stem cell research, and programs and activities for patients and public education.
Apropos the pending Obama administration announcement which will purportedly legalize federal funding for embryonic stem cell research is the following ESCR trial to be conducted at UC Irvine in humans.
To date, there have been no successful ESC treatment applications in humans. Complications have included destructive tumor formation (teratomas) and problems relating to systemic immunity. As is well-known, there have been myriads of successful clinical applications/treatments utilizing adult stem cells and those procured from fetal cord blood.
--Dr. J. P. Hubert
Article Date: 26 Jan 2009 - 0:00 PSTA
Medical News Today
A therapy developed at UC Irvine that made paralyzed rats walk again will become the world's first embryonic stem cell treatment tested in humans.
The U.S. Food and Drug Administration has approved the therapy, based on work by a research team led by Hans Keirstead, co-director of the UCI Sue and Bill Gross Stem Cell Research Center, for a clinical trial in patients with acute spinal cord injury.
Geron Corp. of Menlo Park, Calif., will conduct the clinical trial.
"This trial was approved only after rigorous safety testing and consultation of countless experts in the field," Keirstead said. "Any benefit to the patient, even an incremental one, would be a resounding victory."
The therapy contains human embryonic stem cells destined to become spinal cord cells called oligodendrocytes. These are the building blocks of myelin, the biological insulation for nerve fibers that is critical for maintaining electrical conduction in the central nervous system. When myelin is stripped away, through injury or disease, paralysis can occur.
In laboratory tests, Keirstead and his colleague, Dr. Gabriel Nistor, developed a technique for prompting human embryonic stem cells to develop into oligodendrocyte cells.
Injected into rats with spinal cord injuries, the precursor cells turned into oligodendrocytes and migrated to the injured area of the spinal cord. As the cells wrapped around damaged neurons, new myelin tissue formed, allowing electrical conduction to resume and the rats to walk again.
This success, published in the Journal of Neuroscience in 2005, was the subject of dozens of media stories, including a "60 Minutes" segment.
According to Geron, patients eligible for the phase-one trial must have a certain type of spinal cord damage and be willing to receive injections 7-14 days after injury. Geron has selected up to seven U.S. medical centers that may participate in the study.
UCI has a robust stem cell research program that has received more than $52 million from the California Institute for Regenerative Medicine. UCI's scientists are pioneers in regeneration, large-scale production of specialized cells with very high purity, and methods for treating damaged tissues.
UCI recently broke ground for a four-story building dedicated to stem cell research. When finished in 2010, the building will house the stem cell center, dozens of laboratory-based and clinical researchers, a stem cell techniques course, a master's program in biotechnology with an emphasis on stem cell research, and programs and activities for patients and public education.
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