FDA Goes After Two Stem Cell Clinics

The agency raided one that was using a stem cell-smallpox vaccine combo, and sent a warning to another to obey best practices.

Written byKerry Grens
| 2 min read

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WIKIMEDIA, BESTINPLASTICSLast Friday (August 25), agents from the US Food and Drug Administration (FDA) seized five vials of live smallpox vaccine from a medical outfit in California that was using it in combination with fat-derived stem cells to treat patients with cancer. “The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors,” according to a statement from the FDA.

The day before, the agency sent a letter to Florida-based US Stem Cell Clinic, detailing its deviations from the law. Among them: not having a license for its autologous stem cell treatments, which are given to patients with Parkinson’s disease, Crohn’s, congestive heart failure, and other conditions. The FDA also says the business didn’t ensure sterility of its products, follow proper procedures for cleaning equipment, or require staff to wear clean clothing. US Stem Cell Clinic has 15 days to outline how it will correct the problems FDA detailed.

“Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk,” FDA Commissioner ...

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  • kerry grens

    Kerry served as The Scientist’s news director until 2021. Before joining The Scientist in 2013, she was a stringer for Reuters Health, the senior health and science reporter at WHYY in Philadelphia, and the health and science reporter at New Hampshire Public Radio. Kerry got her start in journalism as a AAAS Mass Media fellow at KUNC in Colorado. She has a master’s in biological sciences from Stanford University and a biology degree from Loyola University Chicago.

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