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FDA cracks down on unlicensed stem cell treatments

The Food and Drug Administration is tightening its grip on clinics using unlicensed stem cell therapies while drawing up a clearer policy surrounding the use of stem cells.

On 25 August, the United States Marshals Service seized vials of a vaccine from a stem cell clinic in California. The vaccine, which is not commercially available, was being used in a stem cell product for cancer patients that had not been approved.

And on 28 August, the FDA issued a warning letter to a Florida clinic for its failure to follow good manufacturing processes that could lead to contaminations of their products. The clinic had been using stem cells to treat heart disease, amyotrophic lateral sclerosis and Parkinson’s disease.

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