It’s not uncommon to see advertisements on the radio or billboards for stem cell treatments, but there’s a catch – current Food and Drug Administration (FDA)-approved stem cell therapies are very few and very select. That means chances are good that any stem cell therapies you currently see advertised have no real scientific backing or oversight. Recently the FDA took steps to shut down these treatments, but enforcement won’t go into effect for another three years.
The FDA closed a loophole in which unlicensed clinics could operate stem cell therapies. The new regulation means any clinic that uses liposuctioned fat to produce stem cells is now considered to be utilizing an unlicensed drug and must obtain a specialized license that allows them to perform the treatment and allows the FDA to inspect the clinic where the procedure is performed. There’s one catch though; the FDA is allowing a 36-month grace period before the new regulation is enforced. A period that many thinks is far too gracious. “Three years is a long time for potentially non-compliant clinics to be still raking in the dough from patients,” observes Paul Knoepfler. Knoepfler is a University of California – Davis stem-cell biologist who focuses on harmful or meaningless stem cell therapies.
The FDA released four policy papers. Two are aimed at regulating legitimate stem-cell research while the other two are aimed at the spread of unlicensed stem cell treatments and clinics. Still, most believe the FDA is not making a strong enough stance like Leigh Turner of the University of Minnesota. “This is nowhere close to a red line; at best, it’s amber,” Turned said about the three-year enforcement delay.
Many clinics around the country are performing unlicensed and unregulated stem cell therapies, but other teams are looking for real evidence-backed therapies that will be safe and effective. Kenneth Pettine of Colorado has completed several FDA studies that test the efficacy of mesenchymal stem cells to treat a variety of chronic conditions like osteoarthritis. Pettine’s early results are promising which means we could see real FDA-approved stem cell therapies in your local doctor’s office instead of bogus treatments.
There are several unapproved therapies on the market that either do nothing or harm you, all at the cost of the patient. Luckily research teams like Pettine’s new evidence with the help of regulation from patient advocates like Knoepfler are helping reduce bogus treatment and bringing real stem cell therapies to patients nationwide.