FDA Reveals Stem Cell Policy Plans Amid Clinic Crackdowns

The Food and Drug Administration campus in Silver Spring Md. Andrew Harnik  AP

"We'll see whether the FDA is prepared to engage in the hard work needed to better regulate this marketplace".

In the California case, StemImmune in San Diego possessed the vials of vaccinia virus vaccine, which was administered to patients with cancer at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, an FDA release stated.

The "potentially risky and unproven treatment" combined a live version of the Vaccinia virus vaccine and stem cells that originated in body fat, and injected them directly into patients' tumors, according to the U.S. Food and Drug Administration. The agency also said the clinic tried to impede the FDA's investigation by refusing to allow entry except by appointment and by denying FDA investigators access to employees. Fortunately, the vaccine is not made of the smallpox virus and can not infect patients with smallpox.

FDA inspectors reported finding that the clinicians there had been injecting the stem cells intravenously or directly into patients' spinal cords.

FDA Commissioner Scott Gottlieb, in a statement on the case, said the agency "will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work".

Aside from the raid on StemImmune Inc, the FDA also sent a warning letter to a Sunrise, Florida-based clinic for marketing stem cell products without regulatory approval and for major deviations from current good manufacturing practices.

The clinic is one of many that tout using stem cells taken from a patient's fat to treat everything from Parkinson's disease to amyotrophic lateral sclerosis or ALS.

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On Monday, the U.S. Food and Drug Administration (FDA) announced that the agency is targeting clinics that offer unproven stem cell therapies, calling such offices "unscrupulous clinics" selling "so-called cures". The article was written by doctors unconnected with the clinic who treated the women for the disastrous results. That hasn't prevented about 570 stem-cell clinics opening that promise to help people with everything from arthritis to Lou Gehrig's disease to any number of other ailments.

Regenerative medicine makes use of human cells or tissues that are engineered or taken from donors. In recent months, networks of chiropractors have run big-budget ads for such treatments in newspaper across the country, including the Inquirer.

In his statement, Gottlieb emphasized that the FDA will draw "bright lines" between new treatments that are subject to FDA regulation, and the therapies that are "individualized by surgeons in such a way that they are not subject to FDA regulation". Numerous individualized treatments fall clearly outside the FDA's pre-market requirements. The field of regenerative medicine, because of the very nature of the science and the rapidly evolving clinical developments, not infrequently lends itself to often close calls between what constitutes an individualized treatment being performed by a doctor within the scope of his medical practice on the one hand, and what constitutes a medical product that is now subject to the authorities Congress has already charged the FDA with exercising. The FDA has published, but has not finalized, draft guidance for stem cell products, saying they can be exempted from the drug approval process under certain scenarios. They can divide and then morph into other kinds of cells - red blood cells, muscle cells, whatever our bodies need.

An agency spokesperson did not have an estimate as to how numerous stem cell clinics now operating around the US would be affected by that guidance.

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