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‘Unscrupulous’ stem cell clinics targeted in FDA crackdown

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This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

The Food and Drug Administration announced a crackdown on dangerous stem cell clinics…while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.

The agency reported actions against two large stem cell clinics and a biotech company, saying that it was critical to shut down “unscrupulous actors”…

Federal marshals seized 500 doses of live Vaccinia virus vaccine for smallpox belonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies for cancer. The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.

StemImmune obtained at least some of the vaccine from the Centers for Disease Control and Prevention, according to Thomas Skinner, a C.D.C. spokesman.

Those enterprises “put the entire field at risk,” Dr. Gottlieb said. “Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.”

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics

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