Nature article on Dr. Centeno


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Published online 17 August 2010 | Nature
FDA challenges stem-cell clinic
Injunction raises questions over regulation.

David Cyranoski

How should clinics that treat patients with injections of their own stem cells be regulated? That question is about to test the jurisdiction of the US Food and Drug Administration (FDA) in a landmark legal battle ? and is fuelling a war of words between doctors marketing such therapies and academics who urge caution.

The FDA asserted its authority on 6 August, when it requested a federal injunction from the US District Court of the District of Columbia to prevent stem-cell clinic Regenerative Sciences in Broomfield, Colorado, from preparing its treatments. The company isolates, cultures and processes adult stem cells from a patient's bone marrow or synovial fluid. Doctors then inject the cells to treat fractures, torn tendons and other ailments. The clinic charges patients US$7,000?9,000, carries out about 20 procedures each month, and says it will fight the FDA's injunction. Unlike conventional bone-marrow transplants of blood-forming stem cells, Regenerative Sciences' procedure relies on mesenchymal stem cells that can potentially transform into bone, cartilage or fat.

In July 2008, the FDA told Regenerative Sciences that its treatments are drugs according to the Federal Food, Drug and Cosmetic Act, and biological products under the Public Health Service Act. But the company did not apply for FDA approval and continued to offer the treatment. Now the agency says that the company is not following good manufacturing practice, and that the treatment's safety and efficacy is unproven.

But Christopher Centeno, Regenerative Sciences' medical director, argues that as the treatment uses a patient's own stem cells, it is a medical procedure akin to in vitro fertilization, and therefore none of the FDA's business. He adds that his treatment has a much better safety record than conventional surgery (C. J. Centeno et al. Curr. Stem Cell Res. Ther. 5 , 81?93; 2010) and that animal (see and imaging (C. J. Centeno et al. Pain Physician 11, 343?353; 2008) studies have proved it effective.

The FDA's demand for scientific evidence from clinical trials "is a valid position. But it is not the only position," Centeno told Nature. He says that it is sufficient to follow the guidelines of the International Cellular Medicine Society (ICMS), based in Salem, Oregon, an association of 1,100 physicians and patients that he co-founded and of which he is medical director.

Centeno and his supporters say that the FDA's request for an injunction is another blow for stem-cell clinics in their David-and-Goliath struggle with an industry-led alliance that wants to put a stranglehold on stem-cell therapies and restrict individuals' use of their own cells. In an open letter on 30 July, ICMS executive director David Audley accused the International Society for Stem Cell Research (ISSCR), based in Deerfield, Illinois, and including some 3,500 stem-cell researchers, of setting out to close their clinics. Motivated by the interests of a pharmaceutical industry unlikely to profit from the treatments, Audley says, the society wants to "change the laws in all civilized countries to outlaw these therapies". When questioned by Nature, however, Audley admitted he had no hard evidence for these assertions.

ISSCR president Elaine Fuchs of the Rockefeller University in New York denies the claims. Although the society gets 12% of its funding from industry, its aim is to "motivate basic science" and not to support industrial interests, she says.

But the ISSCR is worried about unproven stem-cell treatments. In June, it established a service that, on request, will judge whether a treatment or clinic is safe and effective (see Nature 466, 7?8; 2010). Douglas Sipp of the RIKEN Centre for Developmental Biology in Kobe, Japan, and a member of the ISSCR's Task Force on Unproven Stem Cell Treatments, says that "the consequences could be severe" if Regenerative Sciences wins the US District Court case, likely to begin next summer. "Companies would likely feel empowered to ignore requirements for demonstrable safety and efficacy of autologous medicinal products, creating an 'anything goes' atmosphere," he says. "It would be, as they say, a bad thing."

But Centeno senses a landmark victory. "If we win, the entire regulatory structure for autologous cell processing, with or without culture, will be rewritten such that any physician using good practices and treating patients responsibly can use stem cells as part of his or her medical practice," he says.


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Check out phd101 - now telling us we don't get it

This is the same article as the one from
It still needs comments so please add yours as the readership is probably different between the two sites. Here are the comments so far:

jtdwyer at 02:34 PM on 08/17/10
My first reaction was that regulatory agencies stop worrying about non-fetal stem cell research. However, based on the noteriety of stem cells, there is an ominous potential for a return to the pre-FDA days of monkey gland injections... Not by reputable physicians, or course. Perhaps this is really a real job for the AMA, or something.

tamarajorquiera at 06:44 PM on 08/17/10
But certainly not for tha FDA!!!!

patrickking at 11:45 AM on 08/18/10
The fact that human embryo stem cells have a rejection factor makes for a long drawn out process, while adult stem cells using the patient's own cells does not have these risks. You have to look at what patients would be most likely to use in their choices of therapy, not what the govt thinks they should have access to within the USA. Shutting down Adult stem cell clinics is not the way to advance medicine.

StemCellPioneers at 03:22 PM on 08/18/10
As a terminally ill patient, this lawsuit will have a major impact on whether patients will be allowed to be treated with their own stem cells in the U.S. or will have to continue to seek treatment, if able, offshore. Millions of terminally ill patients simply do not have the luxury of waiting for decades while the FDA, Big Pharma, politicians, the ISSCR and the media decide our fates.
I have had treatment offshore which stopped the progression of my disease. I support the ICMS which has published safe stem cell guidelines and a patient registry that could be used uniformly all across the U.S. to allow doctors and patients to make the right choices when choosing where and with whom they get this therapy. I am not buying into any of the scare tactics that are being presented by those that oppose patients trying to save their own lives with their own stem cells. There simply is not the evidence of horrific problems being associated with the use of our own stem cells in treatments used on us. Horrific is the disease I suffer from!
I agree with patrickking. Shutting down adult stem cells clinics is not the way to advance medicine. It is however, the way to buy time for many who have hopes of controlling an industry that involves billions and billions of dollars.
Patients who cannot make it offshore are already paying with their lives. This goes far beyond an orthopedic clinic. This must not be allowed to happen. Patients must be heard.

JudyChalmers at 03:44 PM on 08/18/10
As a woman who contracted breast cancer from an FDA approved drug called Premarin, I have very little faith in their opinions here, and even so I am more suspicious of why they are trying to shut down adult stem cell research for Americans. With the recent fiasco of the Avandia drug getting approval from the FDA and it is still on the shelf shows you where their priorities are today. I thought Obama was going to overhaul the special interest groups like the drug co's that run the FDA? Is this the government that we voted for change? Stem cell research using the person's own stem cells are far more likely to be tapping into our OWN immune systems, not using other people's cells. I also object to the FDA's going after Amish Farmers for selling their milk, I think the FDA has gone off the deep end in stupidity and incompetence which is tied to drug company control of our doctors and medicine that will ultimately lead to a cure for all diseases. Plus this court case is a grand waste of our tax payers dollars -its not the government's money -its ours.

Connie Horn at 06:10 PM on 08/18/10
It is about time someone stands up to the FDA. They are out of control. "We the People" have finally had enough. Thank you Dr. Centeno and Regenerative Science for going to bat for us. The US is lagging behind other countries in this race to cure countless diseases because the FDA continues to stall progress . This seems to be an attempt to give the big drug companies time to figure out a way to profit from the life saving cells of our own bodies. This is a fight we can not afford to loose. Our cells belong to us not the FDA or the Government and it should be our right to use them to save our own lives without interference from any government agency.

phd101 at 06:31 AM on 08/20/10
Readers, the FDA is not trying to shut down RESEARCH on adult stem cells. Rather, they are ensuring proper regulation of their use in the clinic. The treatment under question has not gone through clinical trials to prove the lack of side effects or its real therapeutic value. I, for one, would prefer an FDA stamp on a procedure before I shell out $7000 and put my life on the line.

StemCellPioneers at 04:09 PM on 08/22/10
The following is a direct response to this comment.
phd101 I fully understand what the FDA is trying to do. They are calling our own stem cells drugs. I suffer from a terminal disease like many millions of others in this world. We simply do not have the time, luxury or willingness to wait for years for the FDA to conduct clinical trials on each and every disease that may benefit from adult stem cell therapy. I have been offshore with good results as have thousands of others. Other countries are moving ahead and have clinical trials and treatments available for patients. I simply will not sacrifice myself for a FDA that is trying to take over the practice of medicine in this country. If you were walking in the shoes of someone with a terminal or chronic disease, I doubt your preference would be to die in order for the FDA to get to use its stamp on the procedure that could have saved your life and most likely would have if you would have sought timely treatment at a safe and reputable clinic offshore. The U.S. is behind, plain and simple in medical advancement using adult stem cells, preferring instead to research embryonic stem cells and pursue avenues that will take 20 years or more to become reality in this country. People put their lives on the line daily with FDA approved medical procedures and surgeries, drugs and foods that the FDA has not taken the time to make sure were safe. I have yet to see one shred of evidence that adult stem cells are putting patients lives on the line when used by competent medical doctors. Invasive surgery has far more risks. I simply cannot understand why someone who posts as phd101 isn't more in tune with the needs of patients in this country and how the U.S. is losing out to offshore entities because of a FDA that has overstepped its bounds. It has no legal authority to do what it has done. That's what is not being understood. The court must affirm this so patients do not have to die for the FDA's misguided regulatory policies.

JudyChalmers at 04:20 PM on 08/22/10
People have been waiting far too long for the delays the FDA has put forth in the courts. There is no reasonable excuse for it, while other countries are perfecting adult stem cell therapies, giving treatments to Americans who are healing their diseases the FDA takes clinics to court in this country. Delay, detract, deter any science on stem cells. I would advise those to look at the successes in dog stem cell therapies they are proven to work. If the FDA was at all interested in safety they could start with keeping food safe, our own stem cells are not drugs. I don't need a clinical trial for 20 years to prove my immune system works, but maybe the FDA has to go back to school on this -they are totally out to lunch.
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