BEVERLY HILLS, Calif. — Americans seeking cures from unproven stem cell therapies no longer have to travel to Mexico or Costa Rica to get treated. Clinics promoting such treatments are popping up all over the United States.
A new analysis published Thursday in the journal Cell Stem Cell found 570 clinics, operated by 351 businesses, offering direct-to-consumer stem cell treatments that are largely not backed by science.
Eighteen of the clinics are here in the exclusive enclave of Beverly Hills, with five sprinkled along just a mile-and-a-half stretch of iconic Wilshire Boulevard, tucked among an Aston Martin dealership, Cartier and Bulgari shops, and European chocolatiers. Their websites tout all manner of procedures, from stem cell face sculpting for $20,000 to stem cell “vaginal rejuvenation specials” for $6,970, to stem cell therapies meant to ease arthritis and help patients avoid knee replacement surgeries.
Many of the clinics are part of broader medical practices and are located in generic office buildings. The Reverse Aging Centre in Beverly Hills is a flashy exception: Its glass-lined storefront promises “Stem Cells for Pain” in large white letters. The airy lobby contains nude sculptures, shelves of pricey supplements such as “ultrabiotics,” and dozens of glossy brochures about stem cell therapy. The clinic has one other branch — in Dubai.
Stem cells are highly promising as treatments because they can develop into nearly any type of cell in the body, and in theory could be used to repair or replace dysfunctional cells. Doctors and researchers hope treatments could one day be developed for neurodegenerative disorders, diabetes, and various injuries.
So far, there are few approved therapies. But clinic operators have capitalized on the hype to sell untested procedures directly to patients, with little oversight from federal regulators.
The new analysis, based on online searches, found that California has the most clinics with 113, followed by Florida with 104, and Texas with 71.
“The size of the marketplace we found raises serious questions about whether there has been a significant breakdown in regulatory oversight over unapproved stem cell interventions,” said Leigh Turner, a coauthor of the analysis and a bioethicist at the University of Minnesota.
“It likely costs little to tap into popular understandings of the therapeutic potential of stem cells and reposition businesses as ‘stem cell and regenerative medicine’ facilities,” Turner said. “Profits are likely high, and the likelihood of being punished in some way appears to be very low.”
Clinic operators say they should be exempt from federal regulation of medical procedures because they use cells extracted from a patient’s own body and don’t manipulate the cells much before reinjecting them.
The Food and Drug Administration has left the majority of clinics alone, closing down only a handful in recent years for violations of health and safety.
“The FDA is concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful,” the agency said in a statement.
The FDA is considering more stringent regulation and is planning to hold a public workshop and two days of public hearings in September. The agency had planned to hold the hearings in April but postponed them after being overwhelmed by large numbers of people wanting to comment. Many patients are concerned that the new regulations would shut down their access to experimental treatments.
Andrew Joseph contributed to this report.