In a move that took few by surprise, the FDA has filed a pair of requests for permanent injunctions against US Stem Cell in Florida and Cell Surgical Network in California. Hopefully, this is the beginning of the end for the out-of-control, stem cell wild west, but we still have a nation of chiropractic clinic scams that have yet to be dealt with by the agency. Let me explain.
What Did the FDA Shut Down?
The type of stem cell-therapy clinic that the FDA is focused on right now as “bad actors” is what I call the “fat stem cell miracle cure” outfits. These clinics perform a liposuction and then use an enzyme to digest the structural portion of the fat and then process it further to collect the stem cell fraction. This is called SVF (stromal vascular fraction), which is usually injected IV (intravenous) to try to cure any number of incurable diseases, from ALS to MS to normal aging.
What’s the History Behind This Action?
Way back in 2012, the FDA made it clear that SVF was a drug that would require full clinical trials per medical indication. They have sent out numerous warning letters to various companies since. Both of the companies that were shut down in this action refused to recognize the FDA’s authority to regulate SVF. In addition, both continued to treat patients with risky therapeutic approaches. For example, US Stem Cell in Florida was involved in the treatment of multiple patients who went blind after a nonphysician injected SVF into their eyeballs. Cell Surgical Network was involved in a therapy using the smallpox virus and SVF to treat cancer patients.
To learn more about FDA regulation in this space and what’s legal and what’s not, please see my recent regulatory lecture:
Why Is This FDA Action a Net Positive for Regenerative Medicine?
We have the stem cell wild west out there, and it’s way out of control. Hence, this action is the first step in cleaning that up. Next up will be the crazy chiro clinics using nonphysicians to inject dead amniotic tissue as a live stem cell “cure all.” I’m pretty sure we’ll see action in that round not only against clinics but also against the manufacturers of the amniotic and cord blood tissue products claiming that their dead products have live stem cells. Why? Some of these companies are incorrigible and are violating FDA regulations day in and day out as well as defrauding consumers.
We saw the first domino fall in that world just last week as the North Dakota attorney general’s office took down a chiro clinic offering dead amniotic tissue injections to vulnerable elderly patients. Despite that action, that “bad actor” clinic still has facilities in California and Colorado. What was interesting about that action is that the nonphysicians performing the injections were also fined.
The upshot? The stem cell wild west is just a little less out of control after these FDA actions. However, it’s clear to me that the agency’s next target will be the even more out-of-control sales pitches of amniotic and cord tissue vendors and their sales reps. So stay tuned…”Same bat time, same bat channel…”