Denise Grady & Sheila Kaplan | September 7, 2017 | New York Times
TheFood and Drug Administrationannounced a crackdown on dangerousstem cellclinicswhile 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 forsmallpoxbelonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies forcancer. 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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'Unscrupulous' stem cell clinics targeted in FDA crackdown - Genetic Literacy Project
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