A while back I warned about a company called American CryoStem (ACS) and physicians who were holding a seminar on how fat cells could be collected and culture expanded. You see, this was clearly illegal, but the physician network (who put on the seminar) claimed it was all under an Institutional Review Board (IRB), so it was legal. Turns out I was right, as ACS just received a Warning Letter from the FDA. Let’s review the issues.
What Is Culture Expansion?
Culture expansion means growing cells to bigger numbers in an ideal environment. This can be done with fat or bone marrow stem cells, and it’s what we began doing in the U.S. way back in 2005. However, eventually, we learned that the FDA considered this a prescription drug without approval (despite this being the patient’s own stem cells), and we fought a long legal battle to determine if this was within the scope of the practice of medicine or needed FDA approval. Eventually, the courts sided with the FDA, so we licensed a site in Grand Cayman where this was allowed and only continued in the U.S. with stem cell preparations that the FDA thought were not a drug.
Here are a few interesting articles about our ordeal:
What Is American CryoStem?
I first learned about ACS when a colleague was sent an e-mail from the Cell Surgical Network (CSN). This is a group of physicians using fat-based stem cells. Regrettably, the FDA has recently made it clear that stem cells isolated from fat (called stromal vascular fraction, or SVF) are a drug and can’t be created in a physician’s office. This is despite the network claiming otherwise.
Last January, CSN claimed that they could offer stem cells culture expanded by ACS to their patients under an IRB-approved study. I was shocked as I knew all culture expansion of cells was considered a drug by the FDA that would require approval for each medical indication. Given that the company was offering cells for many medical indications, not even Pfizer could support that many FDA studies. In addition, the company had no biologics license to allow a clinical trial to permit the use of these cells.
The Recent FDA Action
Scott Gottlieb’s FDA has been stating that it will aggressively pursue “bad actors” who are violating FDA rules. Since then there has been a steady stream of FDA actions with the most recent this week against ACS. The FDA stated that its Atcell product, which is culture expanded, is a drug without any FDA approval or license that would allow a clinical trial (what’s called a BLA, or Biologics License Application). The company also had many violations of cGMP drug manufacturing processes, which is not surprising as this site likely uses the much lower processing standard of cGTP, which would be more consistent with processing transplant tissues.
What would posses Cell Surgical Network and ACS to believe that the FDA would allow them to culture expand cells? The ruse was that this would be allowed under an “IRB.” An Instutional Review Board is an organization that can oversee studies, but in this case you would also need a BLA from the FDA to start the research. Hence, none of their position ever made any regulatory sense.
The upshot? You just can’t make this stuff up. It looks like the FDA is making good on its promise to take down stem cell therapy bad actors. I’m sure we’ll see more actions in the coming months.