The New York attorney general, Letitia James, has filed a lawsuit against a stem cell clinic and the sole doctor working there, for allegedly mis-selling unproven treatments to vulnerable patients.
James launched the lawsuit against Park Avenue Stem Cell (PASC) in New York City, New York, and Dr Joel Singer last week on behalf of the people of the state of New York.
The clinic uses stem cells derived from the patients' own fat tissues to treat a range of medical conditions including autoimmune disease, erectile dysfunction, cardiac and pulmonary disease, and orthopaedic and neurological diseases. According to the lawsuit, PASC made misleading claims on its website as well as on social media platforms such as Facebook, Twitter and YouTube about the effectiveness of the treatments.
'Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral,' said James.
The starting price for procedures offered at the clinic is US$3995.
The clinic also made claims that its procedures are supported by existing literature and provided links to articles and scientific studies on its website, but these references do not provide sufficient evidence to support PASC's claims that its procedures can be used to treat the conditions described above, said the lawsuit.
The clinic does include disclaimers on its website, however, according to the lawsuit, they fail to offset the overall impression of the website that their stem cell therapies can be used to treat these various medical conditions.
The lawsuit also alleges that PASC falsely represents that its procedures are approved by the Food and Drug Administration (FDA) and that patients receiving stem cell treatment at the clinic were also made to believe that they were part of a patient-funded research study.
Its website stated: 'This research is part of an FDA approved preliminary study IRB numbers ICSS-2016-001 through ICSS-2016-21.'
In actual fact the FDA does not approve preliminary studies, and most clinical trials are not funded by the patient.
Park Avenue Stem Cell also posted testimonials from Curtis Sliwa, a radio show host, and Darrel Reid, a National Football League player, on the PASC website and Facebook page. However, there was no scientific evidence to substantiate the direct and indirect claims made through these testimonials.
The clinic also failed to disclose the fact that Sliwa and Reid received free treatment in exchange for their testimonials.
Stem cell therapies have the potential to treat many medical conditions 'in the future', said the lawsuit. However, it warned there is currently a lack of scientific evidence to support the use of these treatments in humans and they could be harmful.