This week, the FDA announced that it was sending a warning letter to US Stem Cell in Florida and a California venture known as Stem Immune, linked to the Cell Surgical Network. What do both of these clinics have in common? They both use a product called stromal vascular fraction (SVF) obtained from fat. The FDA has said for some time that this product was a cell drug and not covered under their practice of medicine exemption. I suspect we’ll see more letters in the coming weeks. This crackdown is needed—let me explain.
The Stem Cell Wild West
Having done this work since 2005, I’ve seen the stem cell Wild West begin. At first, it was just a physician colleague who I knew had made up his outcome data from thin air. Later it was the entry of professional business people who saw an opportunity. Finally, it was the rise of the wide mass-media push by chiropractic clinics. There were many opportunities along the way for the promise of regenerative medicine to be self-regulated by physicians, but that never happened. In the absence of medicine regulating itself, someone always steps in to regulate. Be it the FDA, the civil court system, medical boards, or professional organizations.
Way back in 2008, we helped form the International Cellular Medicine Society (ICMS) as a way to self-regulate. The goal was to have all physicians follow strict guidelines on the adoption of treating new diseases with stem cells and track the outcomes of every patient. The problem, in the end, was that the physicians involved didn’t want regulation. They wanted to be able to treat every disease without any impediment or requirement that data be collected. So I moved on from ICMS and focused instead on building Interventional Orthopedics instead.
The First Step Toward an Out-of-Control Industry: The Magic-Fat-Stem-Cell-Pixie-Dust Clinic
Since about 2012, things went from physicians trying new and novel stem cell therapies in select patients to out of control. Much of that initial switch happened because of adipose stromal vascular fraction (SVF) clinics offering to treat every incurable disease known to man. These providers viewed stem cells not as a tool that needed to be carefully deployed in select circumstances, but more as magic pixie dust to be widely sprinkled everywhere. So while we in orthopedic care would begin with simpler treatments, like platelet rich plasma, and only sometimes use stem cells, the fat-stem-cell crowd would begin with magic stem cells injected intravenously and then injected blindly somewhere else. In addition, while in orthopedic care we would wring our hands over who was a good or poor candidate, the magic-fat-stem-cell crowd would consider everyone a candidate. While we would track our patients in registries and report our unfiltered outcomes, the magic-fat crowd would just treat, often while collecting no or minimal data.
The Recent Crackdown
First, the FDA has been telegraphing its punches on fat stem cells since 2011–12. This culminated in draft guidances that were issued in 2014. Last year this came to a head with a public commentary event. All throughout, the FDA has sent a steady stream of Warning Letters to various physicians using fat stem cells.
The recent FDA crackdown was focused on the two groups using fat stem cells. One was US Stem Cell in Sunrise, Florida, and the other was Cell Surgical Network based out of Los Angeles. I had also blogged on both groups starting to culture expand stem cells, another clear drug product without approval (see blog on CSN/American Cryostem and US Stem Cell).
What Is the FDA Action Really About?
The FDA has long pursued a “line in the sand” approach to regulating stem cells. If the cells are minimally manipulated (meaning that the processing has fewer steps), then they are not regulated as drugs. If the cells are from the same patient and part of the same surgical procedure, then they are exempt from FDA regulation under 21 CFR 1271.15(b). Our Regenexx procedures using bone marrow concentrate fit squarely on this side of the line. On the other hand, if the processing is more extensive, then the cells are deemed “more than minimally manipulated” and, as such, are considered cell drugs regulated by FDA under section 351. The recent news stories all pertain to cells that are more than minimally manipulated.
As a company, we have known for some time that these fat-based stem cell products that require extensive lab processing are cell drugs. However, the clinics that have used these products have maintained that they are not drugs. Obviously, with the recent FDA crackdown, there is overwhelming evidence that the FDA considers these regenerative-medicine products made from fat as cellular drugs that are not exempt from regulation and that require full FDA approval involving extensive clinical trials.
The Tip of the Proverbial Iceberg
While the fat-stem-cell crowd has needed reining in for some time, the newest version of the “Stem Cell Wild West” is even worse than the last. Chiropractic groups have gotten their teeth into this industry to offer dead amniotic and cord blood tissue as a “stem cell” therapy. Based on all of the tests I have seen so far showing that these products have no living cells, this is likely massive consumer fraud on a grand scale, stretching itself to every major city newspaper with full-page ads offering the magic of “stem cells.” On the FDA side, the claims of live cells in amniotic and cord tissue make these 351 cell drugs that require full FDA clinical trials before sale or marketing (see video below), which none of these companies have. So, hopefully, the FDA has noticed these full-page ads for “stem cell” products it never approved as such.
The upshot? It is our sincerest hope that the new FDA task force on stem cell therapy “bad actors” continues to clean up the Stem Cell Wild West. While taking out the magic-fat-stem-cell-clinic crowd is a good start, the next big thing is chiropractors injecting dead tissue and claiming it’s an FDA-approved stem cell product!