Since stem cells and other HCT/P’s have come into clinical use in the early 2000s, (starting with one of my maverick doctor clients in the South), the FDA has attempted to regulate the field. Early on, the FDA adopted HCT/P regulations, that would be 21 CRF 1271. These regs made clear that allogeneic and expanded/cultured stem cells were regulated as new drugs. HOwever, there was one giant hole in the regulations, that being autologous, same surgical procedures. That hole in the regulation led to mesenchymal(subsequently determined to be a misnomer) and the SVF (stromal vascul fraction) stem cell business model.
Once that business model started to proliferate and the FDA became aware of the claims being made by these enterprises, it modified one word in the regulation and voila, the regulation turned 1271.15 exempt surgical procedures into a surgical procedural involving an unapproved new drug. Well, at least that is the law in the states in the federal eleventh circuit as a result of the US Stem Cell case. The law may or may not be the same in at least the central district of California depending on how District Judge Jesse Bernal rules in the Cell Surgical Network case. A decision in that case is expected at any time.
I have written many, many posts about this topic. My bottom line has always been that the FDA has as much of a chance to stop the proliferation of these clinics as King Canute had in stopping the tide from coming in. Here is the picture from one of those posts which sums up my thinking about it.
Which brings me to the subject to this post, there is new information that the FDA is losing ground big time in trying to stop stem cell/HCT/P clinics. Apart from my own observations as an attorney in the field, I know this because Paul Knoepfler’s blog, the Niche, just posted a lamentation/hand wringing/pointing the finger of blame at the FDA for failing miserably to reign in these clinics.
In fact, while there used to be an estimated 500-600 clinics back in 2016 when he and Leigh Turner wrote their article about these clinics, he refers to Professor Turner’s just published article that there are maybe 2,700 such clinics now!
Here is Professor Paul’s post. https://ipscell.com/2021/11/turner-pub-charts-runaway-stem-cell-clinic-industry-fda-needs-to-think-big/.
I’ll say it once again: the reason these HCT/P clinics are proliferating is that there is a market for these treatments, especially for certain orthopedic conditions which are refractory to other curative treatments. But market forces alone wouldn’t account for this increase in growth and there has to be something else. As someone who has looked over medical records of clinics and talked to patients, I think I know what is that something else, and it’s pretty simple. The treatment works! At least it appears to, especially in orthopedic injuries and conditions.
I recently came across one such patient successfully treatment by an HCT/P. He was a very athletic fellow. In his 40’s he torn his medial menisci and had surgery. He also tore part of his anterior cruciate ligament. But he still could run (marathons), until he couldn’t. He looked around for a year for a possible treatment, but was told he should stop or reduce running because his cartlidge had worn down too much, at least according to one of the orthopedic surgeons. No place offering conventional care offered him any hope or expectation that he would ever run again.
He eventually found his way to one of those unrelgulated HCT/P clinics, got some autologous material, and boom, he’s back to running marathons. That is what is called by stem cell scientists would call an “anecdote.” True enough, but multiply that by thousands or tens of thousands of other such stories, and that my friends is market force via word of mouth. For sure, not all stem cell anecdotes are positive. I know of some negative ones. But then in medicine, surgery and back surgery in particular, there are no 100% cures for many such conditions. Some patients don’t get better.
I have also reported many times that the industry has moved on to more exotic HCT/P’s including some allogeneic ones. Each time the industry finds a new HCT/P source, the FDA has to start over. The material has to hit the FDA’s radar screen. Then the process of investigating the product, site visits, back and forth communications go on and on.
The Professor suggests that the FDA dispense with the site visits. I don’t think that’s going to happen, at least if the FDA is going to include the product itself in the warning or other letters. The alternative would be if the FDA limits its letters to advertising concerns which might not require a site visit.
And that is a good segway to what the HCT/P clinics should really be worried about, advertising. It is much easier for the government to go after advertising claims> More importantly, there are more governments than just the Feds taking an interest in the advertising of these places. And that would satisfy the Professor’s cry for heavy fines, and the fines for false advertising can be very, very heavy. Even the filing of the lawsuit by the state can do massive damage to the clinic’s reputation.
So, my one piece of advice to all these clinics would be to get your advertising right. You might lose little business, but the more successful and high profile your operation is, the more likely you’ll become a target of some state consumer protection department head which is looking for scalps.
You’ve been warned!
Rick Jaffe, Esq.