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Unauthorized Stem Cell Market Is Booming in U.S.

November 9, 2021

More than 2,750 clinics in the U.S. offer a bewildering array of unauthorized stem cell types hawked for indications ranging from pain to erectile dysfunction to cures for COVID-19 to Alzheimer’s disease.

And business is great, according to Leigh Turner, a professor in the department of Health, Society and Behavior at the University of California at Irvine, whose review in the Nov. 4 issue of the journal Cell Stem Cell outlines the breadth of the problem.

Businesses in the U.S. began selling unlicensed and unproven stem cell products nearly two decades ago, but since 2016, Turner wrote, the number of businesses and clinics selling stem cell therapies has quintupled. The vast majority claim their products and treatments don’t require FDA regulation, despite the fact that FDA does indeed regulate stem cells as drugs or as medical devices that require clinical testing and premarket authorization.

The increase occurred during a time when FDA was only selectively cracking down on the phenomenon, Turner said.

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