It seems like an attractive idea. You get a little fat taken, the stem cells in the fat are isolated and grown to bigger numbers in culture, and then they’re used or banked for future use. There’s just one little problem. All of this is clearly illegal. Let me explain.
Fat Stem Cells
Many tissues in your body have stem cells, and one of these is your fat. These cells can be harvested through liposuction and either injected after chopping up the fat or processed via an enzyme to separate the stem cells from the collagen in which they are stuck (this is called SVF which is short for stromal vascular fraction). If you do the former, the FDA considers this the practice of medicine. If you do the latter, it’s the creation of a new biologic drug, which requires full FDA approval with clinical trials per indication. As a result, the FDA issued two Warning Letters a few months back, and the FBI raided one California clinic.
How can you tell the difference between the legal and illegal use of fat? There are a few telltale signs. Illegal fat clinics commonly advertise IV treatments for many different diseases. In addition, illegal fat clinics sometimes offer banking and culture expansion. Let’s explore those last two.
Culture Expansion and Banking
Once you have stem cells isolated, whether that be from bone marrow or fat, you can then grow them to bigger numbers in culture. That last part is called culture expansion. This process can help some patients who require more cells. However, it’s illegal in the U.S. Hence, we have offered this service through a licensed clinic in Grand Cayman where this is permitted.
However, one of the newer trends is that patients are being offered this service right here in the U.S. How is that possible? For the FDA, this space is like playing a huge game of Whack-a-Mole. They simply can’t keep up.
I’ve noticed this clinic in Utah for a while. What fascinated me was that while it was owned by a chiropractor, it employed a combination of real physicians and midlevels. This is a bit different from your average chiro clinic that employs only midlevels, like physician assistants and nurse practitioners. In addition, unlike chiro clinics only offering dead amniotic and umbilical cord stem cells, this clinic used fat.
Recently, I watched a pay-for-play video on this Utah clinic that was produced by a local TV station. What floored me was that the clinic owner, Robert Bean, DC, got on TV and announced to the world that they offered patients the ability to culture expand and bank fat stem cells! So let’s explore this further.
American Cryostem’s Noncompliant Cell Expansion and Banking
A long time ago, I blogged about American Cryostem (ACS), a company offering stem cell banking. I had identified at that point that Cell Surgical Network was working with them to culture expand and bank stem cells. I had stated that this wasn’t legal, and, sure enough, not long after, American Cryostem got an FDA Warning Letter. Not too long after that, Cell Surgical Network got not only an FDA Warning Letter but also an FBI raid of one of their California offices.
Turns out that the Utah clinic owned by Dr. Bean is a member of Cell Surgical Network and is using the illegal type of fat (SVF) to treat a multitude of diseases. This is something that the FDA has put squarely in their “bad actor” category. However, in a “you can’t make this stuff up” moment, turns out Dr. Bean is not working with American Cryostem to also offer cell culture expansion and banking, but with US Stem Cell in Florida. This is significant because US Stem Cell was the other “bad actor” called out by FDA after blinding three patients. They and Cell Surgical Network are currently the focus of a Justice Department request for a federal injunction to shut these clinics down.
Comments from Dr. Bean
I reached out to Dr. Bean for comment. This is what he stated:
“Hi Dr Centeno, I truly respect everything you’re doing, honestly you’re leading the field. I simply want to do what is best for the patient, as a group we have decided to stick with SVF, I believe it has a great future as does BM. I understand we are taking a HUGE risk with the SVF. Given that there are over 200 doctors in the US offering SVF, I am hoping (probably in vain) that the FDA will pave a path for it’s use. It’s my hope this will happen, if not and we get our cease and desist letter, than I suppose we have no choice but to conform and shut down, or get our providers trained in BM. In fact we are considering it anyway just in case. No matter what, cell therapy is here to stay and we would love to be a part of it moving forward…”
What Will Happen to Your Stem Cells if the FDA Gets an Injunction?
Right now, most legal watchers believe it’s a matter of when and not if the FDA gets granted an injunction on both Cell Surgical Network and US Stem Cell. If that happens, the cells that are banked by US Stem Cell will become misbranded and adulterated drugs. They will not be available for anyone to use. They will also not be easily exported outside the U.S. Hence, if you have cells stored there, they will be gone to you.
The upshot? It blows me away that we still have clinics offering these therapies after the FDA filed for federal injunctions against the two clinics offering them. In addition, the concept that culture expansion is not permitted under current federal law is settled law. Add in that one of the clinics that is being targeted by the FDA for shutdown is involved in offering culture expansion and shipping these cells in interstate commerce from Florida to Utah, and I have to say that I am shocked! You just can’t make this stuff up…