In his latest defiance of the federal government, Gov. Rick Perry is trying to make Texas the nation’s top provider of an unlicensed therapy touted by some as the future of medicine but considered not close to ready for mainstream use by scientists in the field.
Perry this summer worked with his Houston doctor and a state legislator with multiple sclerosis to write legislation intended to commercialize the controversial therapy, which involves injecting patients with their own stem cells. Perry quietly got the therapy as part of back surgery in July.
“With the right policies in place, we can lead the nation in advancing adult stem cell research that will treat diseases, cure cancers and, ultimately, save lives,” Perry wrote the Texas Medical Board on July 25.
The board may squelch Perry’s hope of making stem cell therapy a thriving Texas industry anytime soon. It is scheduled to consider a new policy on Nov. 4 that would prevent doctors from providing stem cell therapy unless they had approval from an independent review committee that assesses research trials for patient safety. Perry’s therapy had no such oversight.
Such a policy likely would head off potential conflict with the Food and Drug Administration, which recently has begun to crack down on stem cell businesses in the United States. The FDA has not approved therapy using adult stem cells because their effectiveness and safety have not been established (…)
The brave new world of stem cell research dangles the exciting potential for a host of leading-edge treatments that may one day help cure debilitating diseases such as Alzheimer’s, Parkinson’s and other maladies that today cannot be treated with modern medicine.
However, not much thought has been given to how those products might be regulated and how issues of legal liability may be addressed in a way that encourages scientific innovation but also protects the patients for whom these treatments might provide great relief.
Now, an attorney and law professor from the UCLA School of Law and a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA has developed a roadmap that could help guide researchers, stem-cell product manufacturers, physicians and patients through the complex maze of imagining, creating and developing stem cell products and using them to treat disease.
“Stem cell research and its eventual applications hold enormous promise, but they also carry some significant risks,” said distinguished professor of law Stephen R. Munzer, whose new article appears April 11 in the Boston University Journal of Science and Technology Law. “Our understanding of the number and gravity of those risks right now is incomplete and uncertain. Developing a plan now that details how to deal with such issues as stem-cell product liability is important because we need to think carefully and rationally about how to address these issues before the market is flooded with products.”
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The Governing Board of the California Institute for Regenerative Medicine, the State Stem Cell Agency, approved a $25 million award to support the first FDA-approved clinical trial based on cells derived from human embryonic stem cells.
The award to Menlo Park-based Geron, Corp, will support the company’s on-going early phase trial for people with spinal cord injury. This is the first time the agency, which was created by the passage of proposition 71 in 2004, has funded a human clinical trial testing a stem cell-derived therapy.
“Supporting the Geron trial is a landmark step for CIRM,” said Robert Klein, CIRM chairman. “However, we must remember that there will be successes and interim failures as human trials proceed through the refinements necessary to achieve a successful human therapy. We need to be prepared to stand by the heroic patients and the companies as they face these challenges and solve the problems that stand in the way of the recovery of patients from paralysis. When the people of California voted for proposition 71 they did so with the hope of seeing new therapies for disabling diseases like Alzheimer’s disease, Parkinson’s disease, diabetes and other chronic diseases and injuries. By funding this trial, CIRM is taking a major step toward making that hope a reality. ”
The initial phase of the trial will include just a small number of people with recent spinal cord injuries who will receive injections of oligodendrocyte progenitor cells derived from embryonic stem cells into the site of the injury. In animal models, those cells mature into oligodendrocytes, which produce the insulating layer surrounding neurons. The initial phase of the three-year project is designed to test whether the cells are safe. Later phases will include different levels of spinal cord injury and will test increasing doses of the cells. One person has already received injections of the cells at a clinical trial site in Georgia. Stanford University Medical Center is another of the trial locations.
Until recently, when a patient suffering a heart attack arrived at a hospital, doctors could open the blocked blood vessel and restore blood flow to prevent further damage. But there was nothing they could do to reverse the harm already done. That damage — scarring that can kill up to 50 percent of the heart — leaves patients with difficulty breathing, loss of energy and the inability to do things such as walk up stairs. Some patients need transplants. And some end up with hearts so weak they die.
The solution: Now doctors can repair that damage. In U.S. Food and Drug Administration-approved trials, a number of hospitals across the country have been injecting the patient’s stem cells into the heart and watching as the damaged muscle is restored to its previously healthy state. The weakened heart becomes pliable again. It contracts normally. And it pumps blood closer to the way it did before the heart attack. That research also found that the earlier the stem cells are injected, the better the heart repairs itself.
But there’s a downside to the treatment.
What might become the first drug derived from human stem cells failed in two late-stage clinical trials, dealing a setback to the drug’s developer and to the stem cell field (…)
Prochymal is a preparation of mesenchymal stem cells, which are obtained from the bone marrow of healthy young adults.
Because the cells are derived from adults, they sidestep the ethical issues stemming from the destruction of human embryos needed to make embryonic stem cells. Unlike most other types of adult stem cells, mesenchymal cells grow well in culture, so thousands of doses can be produced from a single donation.
Stem cells, particularly in the form of bone marrow transplants, are already used in medicine. Osiris is hoping that Prochymal will become the first stem cell product approved by the Food and Drug Administration and sold as a mass-produced pharmaceutical product (…)
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