A rabbit hole in popular culture is when you think you’re trying to find out something simple, but the deeper you dig, the more bizarre and complex it gets. This is what happened recently as I attempted to update my Stem Cell Clinic of America review.
Amniotic Stem Cells
As you know, we have seen an explosion in companies offering amniotic or cord “stem cells.” Why? The barrier to entry is low, and the profits are high. These products don’t go through an FDA approval, but instead a simple online 361 tissue registration. A 45-minute FDA form is all that’s required to start your very own stem cell sales business. In addition, all you need to do is to tap an existing army of orthopedic sales reps to sell your product for a cut of the sales price, and you, too, can have a successful business in a matter of months. There is just one problem: nobody will want to buy your dead amniotic or cord tissue unless you tell them it’s a “stem cell” product. The other problem is that if you push this envelope by advertising that you have live cells in your product (which is likely untrue), then you no longer have a product that will be allowed to be registered with FDA online, but instead a cell drug that will be forced to go through clinical trials. Hence begins the FDA cat-and-mouse game. Claim live cells in a dead product to push sales, but don’t push too hard or you’ll end up being shut down.
Given that no independent testing I have ever seen proves the existence of viable mesenchymal stem cells in amniotic or cord stem cell products, these are like fake Gucci purses. What’s being sold and what’s being bought are two different things. The big difference is that everyone who walks up to a guy selling Guccis on a blanket on the street knows that these purses are fake, and they’ve been priced accordingly. However, patients who are walking in based on website ads for a stem cell procedure don’t know that the “stem cell” procedure they’re getting is fake. In addition, unlike the cheap fake Gucci, it’s priced like a real stem cell injection. It’s as if you buy a $4,000 Gucci purse on the street and pay $3,500, thinking it’s a great deal, until the strap falls off on the way home.
Diversifying the Business Plan
I have reviewed Stem Cell Institute of America before on the blog. At that point, the company was “all in” on amniotic “stem cells.” Since then, I’ve heard rumblings that the company has realized the error of its ways and has now changed the business model for a few clinics. For example, I’ve spoken to a credible source who tells me that in some markets, they’re now using bone marrow and fat stem cell procedures. I’ve also had e-mails sent to me from Florida physicians who have reported that a few sites are also using culture-expanded fat stem cells? That one really piqued my interest. So I asked one of our employees to call a Florida Stem Cell Institute of America (SCIA) site and ask a ton of questions and take careful notes. After all, given that culture-expanded stem cells are a clear drug product and that anyone foolish enough to use these in the U.S. could be in serious trouble for the use of an illegal drug product, I wanted to find out what was really happening.
SCIA and Culture-Expanded Stem Cells
I had our employee start on one of the many Stem Cell Institute of America websites. This one is called “Stem Cell Therapy for Pain.” It has all of the same videos as the other sites that also include Regen America. However, try as they may, our employee couldn’t get anyone on the phone who knew anything about procedures. It seemed like the entire machinery behind the website was to get you to sign up for a free seminar. After speaking to several different people who were only authorized to handle seminar registration, persistence won and a number to speak to someone who may be able to answer questions was finally suggested. Because our employee was inquiring about culture-expanded stem cells, the conversation resulted in the number to a different location where the stem cells were both harvested for banking and the procedure could be done. That location turned out to be US Stem Cell in Sunrise, Florida. An appointment to speak to a physician’s assistant at US Stem Cell was set up. The PA confirmed that the harvesting of the fat for culture, and the reinjection procedure of the banked cells after 6 weeks of culturing could be done there by the PA, or, doses of the cells could be sent anywhere in the country to any physician.
It’s important to note that the physician’s assistant at US Stem Cell confirmed that she would be the one performing the injections, not a physician. This is concerning, as US Stem Cell is the clinic that was recently in the news for being sued by three patients who claimed to be blinded by stem cell injections into their eyes. In those cases, the provider who performed the delicate procedure was also not a physician, but a nurse practitioner. In addition, our employee was informed that no guidance would be used in her knee injections, basically because the stem cells would just find their way to where they needed to be. Anyone who reads this blog knows my position on blind injections.
Also, as discussed above, culturing cells in the United States outside of an FDA-approved clinical trial is illegal. Despite that, we know that a group called American Cryostem is doing it and claiming to be performing a “research study.” However, even the research study is not allowed without FDA approval. However, US Stem Cell seems to be a new animal, it would appear from our research that Stem Cell Institute of America and US Stem Cell have teamed up to offer culture-expanded cells, In addition, there was no talk of a research study or being qualified for same. Even further, US Stem Cell appears to be offering the service to any clinic in the U.S.
You Just Can’t Make This Stuff Up
We were the clinic who fought the good fight to try and get cultured stem cells to be allowed in the U.S. under the practice of medicine. While we lost that seminal fight, one of the things we never did was to act as a service culturing cells for other clinics and sending them back and forth. That seems to be what’s happening here. Why would US Stem Cell or SCIA think that this is OK? Unsure, as it’s clearly against all existing drug laws concerning stem cell use in the U.S.
What Can Happen if You’re a Patient or a Doctor Sending or Receiving Cells?
While patients have less legal exposure, they have more financial exposure if this whole thing gets shut down by the FDA. Why? The cell doses you have banked will be classified as adulterated and misbranded drug products without proper FDA approval. You won’t be able to use these cells for any purpose anywhere. This includes overseas, as exporting an illegal drug product is just as illegal as sending one across state lines.
As a medical provider, this scenario has risks. Section 301 of the FDCA states that it is illegal for any provider to receive a misbranded or adulterated drug product:
- “The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise” [FD&C Act, sec. 301(c); 21 U.S.C. 331(c)].
In addition, you also can’t claim that you just didn’t know. The law is clear that the onus is on the receiver of the illegal-drug product to understand the law.
The upshot? What started out as a second review on Stem Cell Institute of America and trying to understand a complex scheme of many websites and new business models involving chiropractic clinics and physician extenders finally ended up being a major trip down the proverbial rabbit hole. The deeper we got, the more we realized that there is a complex network of relationships that ended up being centered around US Stem Cell who is telling interested patients on the phone that they can culture expand stem cells for their use, all right there in Florida. You just can’t make this stuff up…