StemShot Review II: Is the Umbilical Cord “Stem Cell” Game More About Business than Medicine?
One of the most bizarre things about amniotic and umbilical cord “stem cell” products is that if these products really had living stem cells, they would be illegal cellular drugs in violation of US Food and Drug law. Of course, every one we’ve tested consists of dead and dying cells, so that’s good in one respect, but bad in another. The flip side of that coin is, of course, that if a company claims that these are live stem cell products but they are actually dead, they now have other issues. To that end, one of the marketers of a product that suggests that it contains live stem cells sent out an e-mail to the providers who use the product that blew my mind. Let me explain.
These Products Are Dead Tissue
As a physician, not a week goes by without some orthopedic sales rep contacting you wanting to sell you “millions of live stem cells” derived from amniotic or umbilical cord tissues. The problem, based on our lab testing, is that this is a scam. For more information on how I can say that, please see my video below:
The Scam Moves from Sales Reps to Providers to Patients
Even though these products have no live stem cells, that doesn’t stop sales reps from telling doctors that they do. This takes a tissue that few doctors need for specialty applications and makes it into a blockbuster best seller. How can these providers not know they’re getting scammed? They were never educated in this type of science. This includes orthopedic surgeons (some of the most gullible on the MD/DO side), chiropractors, naturopaths, and acupuncturists. As an example, watch how one company can fool providers with tests that look legit, but aren’t:
This information then gets passed to consumers in seminars (given mostly by chiropractors), which continues to amply the effects of the scam:
These Are All Regulated to Be Dead Cells
Perhaps the MOST bizarre thing here is that amniotic and umbilical cord products that are registered through the FDA 361 pathway are regulated to be nonviable (read dead) tissues. meaning, by law they can’t be alive. For more information, see my video below:
StemShot and the Utah Cord Bank
About 6–9 months ago, I first heard about “StemShot.” As far as I knew back then, this was a product of the Utah Cord Bank. I was concerned that using the word “Stem” in a product name only had one purpose: to convince medical providers that this was a live stem cell product. Let’s dive into the claims.
In February, I had a chiropractor send me an e-mail correspondence from an employee with a stemshot.com e-mail address. That e-mail claimed that there were live stem cells in StemShot. Right now, StemShot is advertised on the Lone Peak Biologics website as an umbilical cord product. the website says:
“In recent years, a unique stem-cell type, called the mesenchymal stem cell (MSC), was identified in abundance in cord tissue. Since then, in multiple studies, MSCs have proven to be a highly capable cell with immense therapeutic potential. Not only that, but new research on the regenerative components within placental and cord tissue is advancing almost daily. MSCs also appear to be heavily involved in the sophisticated process of paracrine cell-to-cell communication.”
Hmmm…It seems like the makers of this product are now only suggesting that it may have live stem cells, without directly claiming that their product has cells (despite the name).Join us for a free Regenexx webinar.
What Blew My Mind
Recently, a consulting physician was working with us to gather samples of products that had claims that they had live stem cells. We had done this testing about 2–3 years ago, but since then many new companies have entered the game of violating FDA regulations and calling likely dead tissue live stem cell products. StemShot was on our list to test for the reason listed above, but when the provider went to reach out to the distributor, he got this e-mail:
“Dear STEMSHOT(R) provider, distributor, or affiliate:
Blue Crab Enterprises, LLC, d/b/a Lone Peak Biologics is the sole owner of the STEMSHOT(R) trademark in the United States in connection with the sale of stem cell products for medical purposes.
Since 2016, we have granted to Utah Cord Bank, Inc. a revocable license to use the STEMSHOT(R) trademark in the United States.
We have become aware of unsubstantiated reports of significant inconsistencies related to regulatory matters with Utah Cord Bank, Inc. As part of our investigation into such reports and to resolve other pending business matters, we made repeated requests for Utah Cord Bank, Inc. to adequately address the matters related to the reports and to validate that its manufacturing processes and products are within FDA regulatory compliance but to date they have not replied to such requests. Therefore, effective immediately, we are no longer associated with Utah Cord Bank, Inc. in any way.
We are no longer comfortable representing that products manufactured by Utah Cord Bank meet our requirements. To be clear, we are not asserting or representing that any specific Utah Cord Bank-manufactured products are deficient in any way. We have revoked Utah Cord Bank’s license to use the STEMSHOT ® brand and terminated the agreement between us because we cannot verify Utah Cord Bank’s compliance with applicable laws and regulations.
All affiliates, representatives, and distributors of Utah Cord Bank, Inc. are hereby directed to immediately cease and desist all use of the STEMSHOT ® mark.
If you have any regulatory or compliance issues or concerns about any STEMSHOT ® product you have received prior to today, please contact the regulatory and compliance department at Utah Cord Bank, Inc. directly at:
All of this seems to have been prompted (as per other e-mails our consultant received) by possible regulatory or processing issues at Utah Cord Bank (UCB). What’s crazy is that Utah Cord Bank put out a press release in January claiming a perfect FDA track record. In fact, at that point, it would seem that StemShot was a UCB product? I’m confused…
While all of this is important information, my concern after reading the e-mail was quite different. The communication reveals the disconnect between a marketing company and its supplier. Let me explain.
Near as I can tell, StemShot isn’t a product, but simply a trademark! Meaning, missing from this e-mail is any discussion of the unique properties of the processing science that this orthopedic device and tissue company researched in the lab and clinic and then licensed. Hence, what I see evidence of is that, like many companies in this space, StemShot is primarily marketing, and the product is outsourced.
The Amniotic and Umbilical Cord Marketing Game
The problem in this space has always been that the FDA regulations that govern tissue processing only allow you to do a certain number of things, all of which are simple. As examples, you can wash, grind, cut, and macerate the tissue. So despite what you read from these companies, they’re all selling very much the same products.
One of the other things we have uncovered is that these companies often outsource the processing and sourcing of the tissue. Meaning, many use the same tissue banks to “private label” similar products, but with very different marketing. Hence, what separates products is less often the quality and medicinal properties and more often the sales pitch.
The upshot? This StemShot e-mail is consistent with what we have seen in this out-of-control and poorly regulated space. Companies really can’t compete on how whiz-bang their processing is and how that creates an amazingly better product because the FDAs very strict laws makes all of the products pretty similar. What they can do is to launch massive marketing campaigns to differentiate their product. The problem, as this StemShot communication shows, is that when marketing is more than science and when a trademark is worth more than the product, “Houston, we have a problem…”