Untested stem cell therapies: regulation and lawsuits

Untested stem cell therapies are acknowledged as a serious concern worldwide. Some patients underwent these dubious treatments experience adverse effects, including death, after receiving these treatments. These therapies were only offered in the developing world in the past. Such procedures exist today even in developed economies like the US and Australia.

There is already litigation against such clinics in the US, some of which have led to settlements. Some of the unscrupulous businesses that offered those therapies are now liquidated. One of the cases is Moorer v. StemGenex Medical Group, Inc. (StemGenex). StemGenex made claims that its product could treat diabetes and a wide range of autoimmune and neurological disorders such as lupus, multiple sclerosis, Crohn's disease, Alzheimer's disease and Parkinson's disease. After inspecting their San Diego facility, the FDA issued a warning letter to StemGenex. “StemGenex™ product appeared to be generated using technology based on a now-expired patent owned by AdiStem Limited. The technology involved adipose-derived stem cells acquired via liposuction and processed with platelet-rich plasma and lights of various wavelengths. The so-called “activated” cell mixture was then administered back to patients (autologously) via intravenous infusion or other routes.