A lawsuit and a warning letter are just two actions of many that the federal government is using in its battle against so-called ”stem cell” clinics across the country.
Federal Government Files Lawsuit Against ‘Stem Cell’ Clinics
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The Federal Trade Commission (FTC) and the State of Georgia together are suing Canton, Georgia-based Stem Cell Institute of America and its co-founders. The lawsuit names the following as defendants: Steven D. Peyroux; Brent J. Detelich; Regenerative Medicine Institute of America, LLC doing business as Stem Cell Institute of America, LLC; Physicians Business Solutions, LLC; and Superior Healthcare, LLC.
The lawsuit alleges that the defendants made false or unsubstantiated efficacy claims about stem cell therapy effectiveness in treating arthritis, joint pain, and a range of other orthopedic conditions. The lawsuit also asserts that the defendants made false claims that the regenerative medicine compliance training program had FTC and U.S. Food and Drug Administration (FDA) approval. Furthermore, the lawsuit claims that the defendants “intentionally targeted elderly and disabled consumers.”
Acting Director of the Bureau of Consumer Protection Samuel Levine commented, “These defendants advertised expensive stem cell injections with baseless pain-relief claims and provided marketing materials and training to chiropractors to do the same.”
Levine continued, “With our partner, the Georgia Attorney General, we aim to ensure they can’t keep preying on older adults and others who need real medical help.”
In a separate action, the FDA issued a warning letter to Sandy, Utah-based Utah Cord Bank LLC doing business as Utah Cell Bank and FIOR Bioscience LLC. The Utah businesses operate from the same location.
The Utah clinic manufactures human umbilical cord blood, umbilical cord, and amniotic membrane derived cellular products for allogeneic use. According to the warning letter, the products are then distributed to health care professionals and medical facilities and are intended to be injected.
After conducting an inspection, the FDA issued the warning letter documenting 14 alleged deviations from applicable current good manufacturing practice and current good tissue practice requirements. The letter calls on the clinic to come into “compliance with all the applicable requirements of the federal regulations.” The letter further warns that if the violations are not adequately addressed, there may be regulatory action.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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