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New rules make it easier for FDA to crack down on unscrupulous stem cell providers, doctors hope

3 1/2 year grace period to file paperwork recently ended
Posted at 6:05 PM, Jun 24, 2021
and last updated 2021-06-24 19:32:51-04

Long considered to be the medicine of tomorrow, the Food and Drug Administration (FDA) describes stem cell therapies on its website as treatments that “may offer the potential to treat diseases or conditions for which few treatments exist.”

But after years of misleading claims by some clinics promising the sick and diseased unproven and, often, unregulated treatments, an FDA grace period has ended making it easier for the feds to identify shady clinics and manufacturers trying to cash in on the stem cell hype.

“Stem cell therapy and regenerative medicine works, it’s actually freaking amazing,” said Dr. Robert Dean of Advanced Regenerative Orthopedics in Tampa. He offers stem cell therapy in combination with nerve ablation. Dean is also now registered with the FDA to sell his treatments as an ‘investigational new drug’ or IND.

The filing period for an IND began in 2017 and ended on May 31st of this year. It allows the FDA to track who’s offering stem cell treatment, what they’re selling, and to whom.

Dean believes this kind of tracking will help clean up an industry plagued with as much deceit as it has promise. In 2018, we went undercover to showcase questionable claims some providers were making about the use and effect of stem cell therapies, much of which remains unapproved and unproven.

As a result of a wave of bad press and stories highlighting the dangerous results some patients experienced after stem cell treatments, by the summer of 2019, Dean said, the industry had taken a hit.

“People were much more critical of what supposed practitioners were trying to sell them,” Dean said.

According to the FDA, since 2018, the agency has issued at least 400 warning letters to stem cell manufacturers and clinics that may be offering illegal products. Since November 2017, the agency has filed just two injunctions, one of them against U.S. Stem Cell Inc, a Broward County, Florida-based stem cell clinic we questioned after several of its patients went blind following treatments.

Dr. Zubin Master, a bioethicist at the Mayo Clinic whose research focuses on regenerative medicine believes the FDA has done a good job regulating the industry but he also believes more can be done if the stem cell industry was standardized globally. Recently, he co-authored a report calling on the World Health Organization (WHO) to get involved. Master, who wrote this report independent from his role at the Mayo Clinic, thinks setting more global standards for stem cell therapy will help better regulate the industry worldwide and dispel misinformation about what is and isn’t approved uses for stem cell treatments.

“How do you combat misinformation in a way that can empathize and sympathize with patients' struggles in this area, but also warn them about the dangers of getting an unproven or unregulated stem cell treatment? Very little work has been done in that area,” Master said.

In a statement, a spokesperson from the FDA told us, “going forward, now that the compliance and enforcement policy has ended, we remain committed to continuing to pursue actions against those who market unapproved stem cell or related products in violation of federal law. We also remain eager to work with those who share our goal of advancing the development of safe and effective regenerative medicine products, including stem cell and related products, to benefit individuals in need.”