Some California stem cell clinics use unproven therapies. A new court ruling cracks down

Stem cell clinics have popped up throughout California, promising cures and relief for arthritis, Alzheimer’s and other conditions through cutting-edge technologies. Some, however, are offering services that have not been approved by federal health regulators.

The U.S. Food and Drug Administration last week gained a significant court win against stem cell clinics that promote and administer unproven therapies.

A three-judge panel on the 9th U.S. Circuit Court of Appeals ruled that the FDA can regulate two affiliated Southern California stem cell clinics and their treatments after a lower court had exempted them from regulation.

The decision, experts say, reasserts the FDA’s authority over regenerative medicine at a time when clinics advertising these types of stem cell products are booming. Unproven therapies have led to infections, disabilities and even death, according to adverse reaction reports.

The case dates to 2018, when the FDA sued the California Stem Cell Treatment Center Inc., which has clinics in Rancho Mirage and Beverly Hills, for “improperly manufacturing and labeling” an unapproved product.

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