On Friday I fielded a patient question and saw a Google ad for amniotic stem cells for sale that were both a demonstration of how the orthopedic stem cell field that I helped create has become a mess. In particular, the ad that popped up in my browser shows a very scary new trend, one that may mean that all stem cell treatments for all patients get further curtailed by the FDA. Let me explain.
The Patient Question That Exposed the Amniotic Mess
Given that I started orthopedic stem cell injections for most orthopedic conditions in 2005, it’s strange to see this field evolving in both some good and some appalling ways. Take, for example, the amniotic “stem cell” scams sweeping the nation. I’ve discussed many times how physicians and chiropractors alike are misleading patients that they are getting live stem cell injections and performing dead cell injections. When this all began, there was little information on what these vials of amniotic tissue contained, so the benefit of the doubt could be given to these healthcare providers. However, in 2016, it’s easy enough to find out that these amniotic “stem cell” products don’t contain live cells, so the clinics and companies selling them as stem cell products should know better.
On Friday I answered a patient question about why an amniotic “stem cell” injection was cheaper than a bone marrow stem cell procedure. I promptly informed the patient that there were no live and viable cells in the amniotic stem cell injection and that the shot he was offered was closer to a platelet rich plasma (PRP) injection, primarily a growth-factor cocktail. Hence, at $4,000, he was paying about 3–4 times as much for a growth-factor shot when compared to a much less expensive PRP injection.
How We Got Here Is Shown by a Disturbing New Ad
Earlier in the week, while preparing a lecture, I ran a Google search to try and find an amniotic stem cell image for the talk. This amniotic stem cells for sale sponsored ad came up:
Buy cryopreserved amniotic stem cell products. Live cell counts, FDA Regulated.”
Given that we often use cells for research purposes in our Regenexx stem cell research facility, I clicked on it, expecting to find one of the scientific supply houses vending cells for “research use only.” What I found was far more ominous. Instead of a science supply company, I found one of the amniotic “stem cell” clinic outfits that is misleading the public by claiming that the dead tissue it injects has live and viable amniotic “stem cells.” Instead of a clinic ad, what I found was a company hawking amniotic stem cells for sale. Yikes! So not only are these companies misrepresenting what they are injecting but now they’re placing ads in Google meant for physicians, claiming to sell live cells, in direct violation of all FDA rules on the subject!
Why Is This Latest Trend Very Scary and Very Different?
Physicians have broad discretion over what is the practice of medicine. For example, a doctor using a procedure in a given patient that uses that patient’s tissue is dramatically different from a regulatory standpoint than a supplier of drug products that’s selling allogeneic products online to any willing physician buyer. In this particular case, there is little doubt that the amniotic tissue supplier described above is an FDA-regulated entity and as such, would need a 351 drug approval to sell live cells to physicians for therapeutic purposes. Why? Isn’t this company already FDA regulated? Not for what’s being advertised and sold.
In the analysis of whether these amniotic stem cells for sale that are being promoted as loosely regulated tissues should be instead much more strictly regulated as drugs, the claims made about this product become critical. If the claims simply discuss that the tissue is processed this way or that, no problems. However, once claims are made about live cells and how those cells may cure disease, that’s different. Here are some claims made at this website:
“Amniotic stem cell therapy is now mainstream and it works very well for many medical conditions. The product we offer has LIVE stem cells with certified cell counts and is processed at an FDA regulated lab that is also AATB Certified. We can meet or beat your current pricing over 95% of the time!”
1. Amniotic stem cell therapy is effective for many medical conditions.
2. The product has live stem cells.
Regardless of whether this product has live stem cells (given what we’ve seen, it would be very unlikely that it had live stem cells that were capable of anything other than becoming quickly apoptotic or dying), the claim that this product has them changes the regulatory status. These claims move it from a voluntary and inexpensive 361 tissue registration into the world of an expensive and strictly regulated 351 drug.
Here are more examples:
Musculoskeletal and Spine
Orthopedics & Pain Management
Wound Healing Issues
Depending on how you read this, this product is being offered to treat at least 5 or 6 to 20 or more medical indications. Again, all claims that for an FDA-regulated product transform it from a 361 tissue into a 351 drug.
Now that we know that this product is not a loosely regulated tissue but instead a controlled drug, the big problem becomes that this drug product has no FDA approval. Since this distinction is where both physicians and patients get confused, let’s delve a little deeper into the differences. The gulf between what a 361 tissue registration entails and a 351 drug product needs for approval is broad and deep.
The ad copy claims that this product is FDA regulated, but while that’s technically correct, when you understand cell drug regulation, it’s deceiving. The 361 tissue registration filed for this product is an online form that’s filled out by the manufacturer. There are no clinical trials required nor drug approval process. Submit the form, and you’re done.
Contrast that simple 361 registration to a highly complicated, expensive, and time-consuming FDA cell drug approval. For the latter, there are preclinical experiments in animals that must be performed costing $1–3 million. Then the manufacturer must file for a biologics license, which will easily cost another $2–3 million. Then phase-1 trials will run another $1–3 million, phase-2 trials another $5–20 million, and phase-3 trials yet another $20-300 million. All of this takes somewhere around a decade to complete.
Also, while the physical site where these amniotic products are processed may have an AATB (American Association of Tissue Banks) registration, that means nothing to FDA if this tissue is considered a drug product. That’s because drugs are manufactured under much more stringent cGMP (current Good Manufacturing Practices). Any AATB site would fail a cGMP inspection across the board, as these drug-manufacturing regulations are far more extreme than a tissue processor could handle. Also, any surgery center or hospital would also fail.
In summary, the simple online registration that this amniotic product claims pales in comparison to an actual drug approval. Once this product is determined to be a 351 drug and not a 361 tissue (the existing voluntary registration), it needs a separate, full 3-phase and hugely expensive drug approval trial for every medical indication listed!
Why This New Trend Is Not Good for the Field
Physicians who are legitimately trying to use the patient’s stem cells or other autologous tissues to help patients have long argued that this is the practice of medicine and that the FDA has no right entering the regulation of medical practices. Many credible and compelling arguments can be made that the FDA is overstepping the law by regulating autologous tissues used by doctors as drugs. In fact, an impressive array of luminaries and experts showed up at the FDA hearing last month to argue just that. However, this new ploy to sell unapproved allogeneic stem cell products direct to physicians gives the FDA exactly what it needs to render meaningless all of the hard work that went into the effort to support a patient’s right to use his or her body parts. Why? While there is little doubt that the FDA doesn’t regulate the practice of medicine, there is also little doubt that it does control allogeneic tissues and cells. Hence, an entrepreneur trying to sell unapproved cell drug products online to any willing buyer gives the FDA the high ground in the argument against allowing any stem cell treatments to be performed. Why? They can now point to an area they clearly regulate and say with a straight face, “Look at how out of hand this stem cell treatment space has become.”
The upshot? This online amniotic tissue sales scheme is a new twist in the never-ending saga of consumer-level fraud that’s occurring with amniotic products. On the one hand, these products may contain important growth factors and may work more or less like an expensive PRP shot. On the contrary, they’re clearly not stem cell products. Now, by selling these products directly to physicians online and claiming that they have live cells that are effective for many indications, a new bright line has been crossed. No longer is the issue the physician’s right to use the patient’s cells the universal and compelling rallying call. Instead, the FDA has been provided with ample evidence that tighter regulation is required to rein in an “out of control” free-for-all stem cell treatment space.
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…