FDA Violates Mandate – Unauthorized Change Undermines Most Promising Stem Cell Research

(Stem Cells News image)

Christopher J. Centeno, M.D.

Christopher J. Centeno, M.D.

A leading adult stem cell therapy organization is warning the public that the Food and Drug Administration (FDA) has teamed up with the pharmaceutical industry to declare a person’s own stem cells to be a “drug” which can be regulated, thus slowing down the progress of these promising therapies by requiring years of clinical trials before use.
Dr. Christopher Centeno, of Regenerative Science, Inc. of Broomfield, Colo., realized what was happening when he was contacted by the FDA last summer about his work using a patient’s own stem cells to regenerate bone and cartilage.

“The FDA contends that if one cultures stem cells at all, regardless of the use of those cells, then it’s a prescription drug,” said Dr. Centeno.
By declaring adult stem cells to be a drug means subjecting each application to 7-10 years of clinical trials before approved use.

“So while your doctor could do all of this safely in a physician-run lab and begin treating a host of diseases, you have to wait 5-20 years for access to your own stem cells (as a drug),” Dr. Centeno said. (…)

“If we can treat your heart failure with your stem cells, send them to the lab down the street where they’ll process them, and we’ll put the cells back into you — that would dramatically and negatively compete with the big pharma embryonic stem cell business model,” he said.
Dr. Centeno, who established an organization to define guidelines and standards for adult stem cell research called The American Stem Cell Therapy Association (ASCTA), hired a team of lawyers last summer to challenge the FDA’s assertion.

It was during this process that they discovered a critical change had been made in 2005 to the agency’s definition of human cell tissue or tissue based products, known as HCT/P’s. This change is what now allows adult stem cells to fall into the category of a biological drug. (…)

By changing one simple phrase, the agency has given itself sweeping new powers to regulate stem cells as biological drugs. But this change is problematic for the FDA because it amounts to a new regulation, something they are not authorized to make without notifying the public and offering the public the opportunity to comment. (…)

“First, the FDA has itself acknowledged that there exists a low risk of the spread of communicable disease when adult stem cells are taken from the patient and re-implanted into that same patient. Moreover, if the FDA asserted its jurisdiction over any product or procedure which involved the slightest possibility of contamination, the FDA would thereby regulate every hospital and doctor’s office in the country. The sorts of contamination to which Ms. Peper refers are commonly called ‘infections.’ An infection is a medical complication, not a federal public health issue.”

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