I get contacted all the time with interesting stuff and this morning I woke up to a flyer from an acupuncture clinic in Portland, Oregon called “A New Way Clinic”. I’d like to review the accuracy of what was claimed in seminars about the “stem cell” procedures being offered and the flyer. So let’s dig in.
Stem Cell Seminars
The idea of giving a seminar to educate patients is fine. Hospitals do it all the time to advertise their new joint replacement programs. However, the problem begins when the information provided is demonstrably false or misrepresented.
The person who sent me the information attended a seminar put on by Tal Cohen, an acupuncturist from “A New Way Clinic” in Portland, Oregon. This is what was reported to me as relayed during the seminar:
- 400,000 stem cells per 1 cc when using an amniotic source (lower cost product for younger patients)
- 4-12 million stem cells when using from the umbilical cord.
- These stem cells stay in your body for 2-5 years.
So let’s review those statements and then we’ll take a look at a flyer from the clinic that was sent to me.
Stem Cell Numbers?
First, let’s dig into the idea that amniotic fluid (the stuff that surrounds the baby in the womb) has 400,000 stem cell per ml as sold and as available to Tal Cohen’s “A New Way Clinic”. While amniotic fluid has a few stem cells when it’s fresh and cultured right away in a lab (1), multiple research studies have now demonstrated that commercially available amniotic fluid has no live and functional stem cells after it’s harvested, processed and manufactured, frozen, and sold by commercial vendors to clinics (2-4). Hence this claim that the amniotic fluid that the clinic uses has live stem cells is false.
Next, the person that attended the seminar found out that they use an umbilical cord product manufactured by Utah Cord Bank. So does it have 4-12 million stem cells per vial? We tested this by plating the StemVive product obtained from Utah Cord Bank, it was all dead tissue with no living cells, let alone living stem cells. In fact, the product had very poor initial viability and this only got worse over 24 hours in culture. By that time it was all dead. We then had Colorado State University confirm our tests which also showed all dead cells. So the assertion that the umbilical cord product used by Tal Cohen and “A New Way Clinic” has millions of live and functional stem cells is false. Obviously, if the cells are dead, they will be quickly eliminated by your body as foreign tissue, so they won’t stay in your body for 2-5 years.
This is the top of the brochure:
OK, so now I’m expecting “The Truth”. Let’s check that! We see this next:
This is an MRI that looks like it was taken from some publication in 2017. I did find the paper which is here. The problem? The cells used were not those from Utah Cord Bank, but a cell product that was cultured and manufactured and that is not available for use in the US or any other country at this time. Hence, what’s shown is NOT what happens with the product being used by this clinic. Next up:
First, tissue manufacturers are not “approved and certified”, they instead go through a free 45-minute registration online. The FDA can inspect the facility at any time, but issues no approvals nor certifications, only warnings if they find problems with sterility or processes. In addition, reporting and tracking “side effects” are not part of this type of FDA 361 tissue registration. For example, what’s being alluded to here is the type of published side effect profiles that are available for FDA approved drugs that the agency reviews and approves. Again, no such approval was granted here, just a simple 45-minute online registration.
This is a ProPublica story on the Utah Cord Bank. From that article:
“Industry insiders and the two former employees said that one placenta should yield between two and four hundred vials of amniotic stem cells. The Utah Cord Bank would harvest as many as eight hundred, the ex-employees said. Also according to the former employees, it costs less than fifty dollars to make a single vial, which is then sold to a clinic or a distributor for about a thousand dollars.
Spencer also used expired chemicals and reagents in his lab, according to two former employees. In January, 2018, the F.D.A. sent an inspector to the Utah Cord Bank to audit it for compliance with regulations on laboratory operations, according to the FDAzilla database, which tracks inspections. After the inspector notified the company that she would arrive on a Monday, workers spent the previous weekend getting rid of expired materials, two former employees said. In a statement to The New Yorker, Spencer denied ever using expired chemicals or reagents in his lab. The bank passed the audit.”
The upshot? So are the statements made by Mr. Cohen at the seminar and those in the brochure accurate? Not based on what’s been published or presented at medical conferences. In addition, the brochure (and the website which I didn’t review here) is rife with scientific citations that have little to do with the type of umbilical cord product that this clinic uses. Finally, the regulatory statements made in the brochure are also not accurate.
(1) Srivastava, M., Ahlawat, N. & Srivastava, A. Amniotic Fluid Stem Cells: A New Era in Regenerative Medicine. J Obstet Gynecol India (2018) 68: 15. https://doi.org/10.1007/s13224-017-1034-z
(2) Dustin R. Berger, Nicolette F. Lyons, and Neven J. Steinmetz. In Vitro Evaluation of Injectable, Placental Tissue-Derived Products for Interventional Orthopedics. Interventional Orthopedics Foundation Annual Meeting. Denver, 2015. https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf
(3) Liliya Becktell, Andrea Matuska, PhD, Stephanie Hon, DVM, Michelle L. Delco, DVM, PhD, Brian J. Cole, MD, Lisa A. Fortier, DVM, PhD. Proteomic analysis and cell viability of nine amnion-derived biologics. Orthopedic Research Society Annual Meeting, New Orleans, 2018. https://app.box.com/s/vcx7uw17gupg9ki06i57lno1tbjmzwaf
(4) Panero, A. J., Hirahara, A. M., Andersen, W. J., Rothenberg, J., & Fierro, F. (2019). Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine, 47(5), 1230–1235. https://doi.org/10.1177/0363546519829034