Staying Fit
The U.S. Food and Drug Administration is seeking to shut down two stem cell clinics, one in Florida and one in California, citing the "serious and permanent harm" they have caused. Working through the Justice Department, the FDA sought permanent injunctions against the clinics last week, following crackdowns beginning last year.
FDA Commissioner Scott Gottlieb, M.D., said that while cell-based regenerative medicine — using the body’s own “master cells” to strategically repair or replace damaged cells where needed — holds great promise, such “bad actors” as these two clinics “leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk.”
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He also cited the clinics’ “inadequate manufacturing conditions” that could lead to the contamination of purportedly sterile products and to patient infections.
In an August 2017 investigation, one of the clinics, the California Stem Cell Treatment Center, was found to be mixing stem cells harvested from patients’ body fat with smallpox vaccine before injecting it directly into the tumors of cancer patients. This, the FDA noted, created the possibility of inflammation and swelling of the heart and surrounding tissues in patients with already compromised immune systems. The clinic was also using its stem cell products to treat patients with everything from arthritis to diabetes — as well as those with diseases such as amyotrophic lateral sclerosis (also known as Lou Gehrig's disease), multiple sclerosis and Parkinson’s.
