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FDA, In the News, Stem Cells

FDA audit of Texas stem cell clinic revealed by Houston Chronicle

I haven’t written much about it here, but I’ve been following carefully the ongoing drama between the Food and Drug Administration and a Texas stem cell clinic, Celltex. (Texas Governor Rick Perry underwent experimental injection of his own adult stem cells last year, and thrust Celltex into the spotlight.) Today the Houston Chronicle published portions of documents from an agency audit of the clinic in April, obtained through a Freedom of Information Act filed by University of Minnesota bioethicist Leigh Turner, PhD. According to the paper:

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

At issue is whether Celltex, or other similar companies, can remove adult stem cells from a patient, culture them in a lab and then reinject them into the same patient from which they were derived. U.C. Davis stem cell researcher Paul Knoepfler, PhD, included on his well-regarded stem cell blog a damning comment today from Turner:

Since February, many individuals have expressed both concern and outrage in response to Celltex’s involvement in processing mesenchymal stem cells, banking stem cells, and making these cells accessible to individuals with such illnesses as multiple sclerosis and Parkinson’s disease.  Among various issues raised by bioethicists, scientists, journalists, and other individuals who have investigated Celltex’s operation in Texas are fundamental questions about whether the stem cells Celltex provides to patients are safe and effective. Celltex has failed to make any attempt to demonstrate safety and efficacy and yet it charges patients with serious illnesses $20,000 to $30,000 for stem cell “infusions.” There is no reason to assume that these procedures are safe and effective.  To the contrary, by providing local physicians with clinically unproven stem cell interventions Celltex is putting patients at risk of harm.

The California Institute for Regenerative Medicine also weighed in today, no doubt trying to mitigate any overall negative fallout for the field of adult stem cell research, emphasizing how important it is for stem cell companies to work with regulators like the FDA to bring the best therapies to patients.

The as-yet-unresolved role of Celltex and other adult stem cell clinics in this country is one all stem cell researchers and reporters should be watching with interest. It pits patients, many of whom feel their own stem cells (and how they and their physicians choose to use them) should not be subject to government oversight, against regulators who argue that these cells (once removed from the body and grown in a laboratory) should at least be shown to be safe and effective before the technique is commercially marketed to patients.

Previously: Stanford’s Irving Weissman on the (lost?) promise of stem cells, Stem cell researchers challenge clinics’ questionable practices, and Bioethicist Arthur Caplan slams unproven stem cell clinics

2 Responses to “ FDA audit of Texas stem cell clinic revealed by Houston Chronicle ”

  1. James Stevens Says:

    This is an unwanted and unneeded controversy. I challenge the government agency to outline and research the necessary protocol to insure safe use of stem cells. Is there research to further the use of stem cells in the clinical setting or are we just setting guidelines to limit the use of this new found technique?

    Where is the leadership on this matter? Why can’t guidelines be established where stem cells can be enhanced? We seem to be stuck in a morass of bureaucratic red tape with no discernible way toward progress.

  2. Brenda Kelly Says:

    Re:Autologous Stem Cell Therapy

    I have arthritis and have been waiting for at least five years for stem cell therapy to become available to me. I do not want to undergo knee or hip replacement surgery. I think that my stem cells should remain my own when harvested and I should be allowed to benefit from procedures using them. I understand the need to legislate to insure safety for the patient but the risks appear to be less than those from surgery. BRENDA K

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