Judge Rules in FDA’s Favor Against Fat Stem Cell Clinic Chain
A Florida district court judge ruled yesterday that US Stem Cell was violating the law and producing an unapproved drug by using stem cells from adipose tissue to treat a myriad of incurable diseases. This marks the first of two rulings due on clinics who manufacture Stromal Vascular Fraction (SVF) and inject it IV. It’s also another step in cleaning up the stem cell wild west.
What is SVF? What’s Going On?
SVF is created from adipose tissue obtained via liposuction. The tissue is then exposed to an enzyme that breaks down the structural component of fat and releases many different cells including a small portion of stem cells. The clinics that use SVF have usually injected it IV and treat a laundry list of incurable diseases with the product. The FDA began declaring it a drug that needed extensive clinical trials and approval in 2011 and 2012 with various warning letters. However, many SVF die-hards claimed for years that these letters didn’t apply to them. Finally, in 2017 the FDA moved against two SVF clinic chains, US Stem Cell, and Cell Surgical Network, by filing in court to stop the production of SVF without FDA approval. The judge in the US Stem Cell Case ruled in the FDA’s favor yesterday.
How Does this Impact “The Stem Cell Wild West”?
While helpful in reducing the number of physicians in Florida and California using SVF to treat patients, the major portion of the industry that’s still out of control is represented by clinics offering birth tissues. These are usually chiropractic clinics or other alternative medicine practices who make bold claims about injecting millions of live stem cells, but in fact, are injecting dead tissue. While many letters have been sent by FDA to at least 50 or more of these clinics, they still advertise aggressively and prey on the sick and the elderly.
The upshot? Hopefully, this goes a long way in cleaning up the stem cell wild west. In the meantime, it’s just the beginning of the enforcement actions coming down the pike.