New York State Attorney General Letitia James has sued a Manhattan stem cell clinic for allegedly scamming patients into believing the clinic could cure them of conditions such as autoimmune disease, cardiac/pulmonary disease, and orthopedic diseases.
New York AG Says Stem Cell Clinic Was Scam
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According to the lawsuit, Park Avenue Stem Cell and its managing doctor, Joel B. Singer, M.D., falsely advertised that its treatments could “improve” or “treat” conditions such as urological disease, erectile dysfunction, neurology disease, cardiac/pulmonary disease, autoimmune conditions and orthopedic conditions.
The complaint alleges that the clinic misrepresented that its procedures were FDA-approved, that its patients were participating in an established research study, and that its procedures had been endorsed by numerous scientific and medical organizations. Some patients were told that multiple treatments were necessary.
In the United States, stem cell treatments are regulated by the Food and Drug Administration (FDA). Currently, the FDA has only approved one or two stem cell treatments and those are for very specific and complex medical conditions. Under the 361 Human Cell and Tissue rules, the FDA is monitoring a large number of human derived cord-blood or amniotic tissue products and just recently sent out 20 warning letters to so-called “stem cell” processors.
Park Avenue Stem Cell used stem cells from patients’ own adipose (fat) tissue and used it to treat a number of conditions that have not been approved by the FDA.
Park Avenue Stem Cell was previously affiliated with the Cell Surgical Network, a California corporation that was sued by the FDA for administering stem cell products that were not approved and misbranded or adulterated. The FDA is currently seeking a permanent injunction against Cell Surgical Network, its main doctors, and a related entity.
Attorney General James released a statement saying, “Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral…. We will continue to investigate these types of clinics that shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are unproven.”
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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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