A federal court just affirmed the FDA’s claims and injunction against against US Stem Cell and two of its employees/principals.
Basically, the federal court once again confirmed that adipose tissue and especially enzymatic digestion of adipose to make an orthobiologic called SVF is NOT allowed unless the product is properly regulated by the FDA as a biologic drug. US Stem Cell did not properly register their processes or products and on inspection the FDA found many deficiencies in their business practices. Basically, this will have the effect of shutting down US Stem Cell’s adipose tissue “stem cell” practices in the USA. It also means that The Cell Surgical Network, another similarly operating chain of clinics, will likely have the federal court action upholding the FDA injunction against its network. The FDA has moved first against these two networks in part because of horrendous complications that clinics in both networks caused with improper drug creation and processing and delivery….along with flawed medical protocols that in Florida led to the blindness of several patients.
The new FDA director looks to be continuing the FDA enforcement actions and let’s hope that these efforts continue!