Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency.
R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website.
There’s a lot of subtext in the FDA letter and accompanying PR, in my view none of it good for the company or its “centers of excellence.”
The R3 website also includes a number of patient testimonials (see screenshot), but I cannot really tell how much hard biomedical science is behind what they are offering. My prediction would be not much. I just covered another similar supplier, Liveyon, and the wider perinatal stem cell clinic world here a few days ago in a piece that also quoted from an excellent article by Caroline Chen at ProPublica that had included some material on David Greene as well.
R3 seems to be an important part of the problematic perinatal stem cell subsector of the unproven stem cell clinic world.
What I would call a “mini-warning” letter came in the form of an untitled letter that was further described in the FDA PR here.
A key passage from the PR:
“The U.S. Food and Drug Administration has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona, and its chief executive officer, David Greene, M.D. The company, through its affiliated centers or clinics throughout the U.S., offers unapproved stem cell products to treat a variety of diseases and conditions, such as Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS). The products offered by R3 Stem Cell, LLC are not approved by the FDA.
The FDA has notified each of R3 Stem Cell, LLC’s more than 50 affiliate centers or clinics of this action.”
I appreciate the fact that the FDA included the 50+ clinics affiliated with R3 in the notice. This is kind of akin to the FDA Including the full Cell Surgical Network chain of clinics as a defendant in its suit against California Stem Cell Treatment Center.
You can read the actual untitled letter to Dr. Greene here.
The FDA noted that R3 Stem Cell seems to be suggesting that their stem cell products can effectively be used for some extremely serious health conditions that, in my opinion, cannot today confidently be addressed using stem cells including ALS and Parkinson’s Disease.
There is so much false hope being sold more generally.
The FDA further indicated that R3 Stem Cell’s product is likely to be a drug and thus by law it requires premarket approval. In other words, the product almost certainly needs FDA vetting and a cleared IND (and probably R3 needs a BLA) prior to being sold to and used in patients at the clinics.
FDA Acting Commissioner Ned Sharpless, M.D. had some strong words for the stem cell clinic field in this PR as well, which in my view likely reflect strong agency views specifically on R3 Stem Cell itself.
From CBER Director Peter Marks, we also got a nice summary of all the actions taken more broadly by the FDA recently on unproven stem cell clinics and suppliers:
“Over the past year, the FDA has sent 46 manufacturers and health care professionals regulatory correspondence, including today’s untitled letter. We have also sent warning letters, and we have two court cases pending. We’re committed to taking appropriate steps to address those that jeopardize public health.”
I also like how the FDA gave practical steps that consumers or health care providers can take if they are concerned here:
“Health care professionals and consumers should report any adverse events related to treatments with R3 Stem Cell, LLC products and/or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.”
This action definitely seems a step above the many “mini-warning letters” that the FDA has sent out in the past, which were never made public. Hopefully, R3 Stem will have to seriously reconsider what they are doing. I don’t know why the FDA sent R3 an untitled letter instead of a warning letter given the nature of the issues mentioned.
More letters of various kinds from the agency to clinics are likely in the works. I hope they don’t wait until next year to take more actual actions as well as many patients are still at risk.