Amniotic Stem Cells for Sale Online?
POSTED ON 10/23/2016 IN Regenerative Medicine Education BY Christopher Centeno
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:
"Amniotic Stem Cell Supplier—Live Stem Cells, Low Pricing.
Ad www.amnio...products.com/(8...) 43..-7..6
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:
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