FDA advisory panel votes against approval of DMD drugIt’s common knowledge that in countries with few (or very relaxed) medical regulations, consumers can have an easier time procuring drugs that in the U.S. would require prescriptions of the patients and government oversight of the manufacturers. The same holds true for newer science, like stem cell medical interventions—they aren’t difficult to obtain in certain points on the globe.

However, the truth is that the U.S. has also had a rash of clinics offering stem cell interventions without operating under the strictest level of regulation the government requires.

In an effort to more closely monitor medical clinics that provide unapproved stem cell treatments, the U.S. Food and Drug Administration held a public hearing on Monday and Tuesday in Bethesda, Maryland entitled, “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.”

Approximately 100 physicians, researchers, and stem cell clinic representatives were slated to testify at the hearing.

Hundreds of stem cell clinics across the country; California has highest number

A recent study appearing in the journal Cell Stem Cell reported that nearly 600 U.S. clinics presently offer stem cell therapies for medical and cosmetic purposes (over 100 in California alone, the highest density of any state). The facilities tout success across a wide range of medical conditions, including autism, spinal cord injuries, Parkinson’s disease, Multiple Sclerosis, cerebral palsy, COPD, and ALS.

The study’s authors, Leigh Turner of the University of Minnesota and Paul Knoepfler of the University of California, Davis expressed worry in light of their findings: “There are clear grounds for concern that some of the companies we found are not compliant with federal regulations.”

Many of what Turner and Knoepfler refer to as non-compliant clinics purport to use stem cells extracted from patients’ own fat. Those clinics contend that those treatments should not be subject to the FDA’s painstaking approval methodology because the adipose tissue is “minimally manipulated” and therefore should be exempt from classification as a drug and subsequent strict oversight by the agency.

That argument failed to convince the FDA that it should be hands-off with those clinics.

And no one knows that better than Dr. Thomas A. Gionis, Surgeon-in-Chief and Owner of the Irvine Stem Cell Treatment Center in Irvine, California, the Manhattan Regenerative Medicine Medical Group in New York, and the Miami Stem Cell Treatment Center in Boca Raton, Florida.

In late 2015, following government inspections of his clinics, Gionis received a letter from the FDA not only citing several inspection failures, but also warning him that the processing of adipose tissue in his clinics “would not meet the definition of minimal manipulation”; therefore, his products were considered drugs requiring the highest level of agency approval (a costly and exhaustive process).

And of course Gionis’ facilities and practices are not the exclusive focus of the FDA’s tougher approach, but rather one example in what is likely to be a very long line.

Stem cell supporters and researchers worry that strict FDA regulations will impede advancement in this area of medicine

There has been a spike in safety concerns in the stem cell field; some patients have developed tumors following treatment, some have lost their vision. Undoubtedly, these cases have led the agency to proposing a rigorous approval process and strict regulation for this heretofore lightly-regulated therapy. However, proponents of stem cell treatments worry that intense involvement by the FDA may close down clinics and prevent patients from obtaining the medicine they need.

The public hearing was not meant to address that question, but rather, to “obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products.” In addition to welcoming feedback on the FDA drafts from the public in general, the agency asked for the opinion of “a broad group of stakeholders, including tissue establishments,” and “biological and device researchers.”

 

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