Stem Cell; the US Food and Drug Association (FDA) sent an untitled letter to R3 Stem Cell LLC charging the company with significant violations of the Public Health Service Act (PHS Act) for offering unapproved therapies. Following a review of the R3 website, the FDA’s Office of Compliance and Biologics Quality; but sent the letter to R3 Stem Cells CEO David Greene, MD, MBA; in Cave Creek, Arizona, and to over 50 affiliated centers or clinics.
An untitled letter from the FDA, such as the one sent to R3; is slightly less serious than a warning letter and is typically; but seen as an initial correspondence that cites violations of the PHS Act; not meeting the threshold of regulatory significance of a warning letter.
Regenerative stem cell therapies
The agency says that the “regenerative stem cell therapies” offered by R3 Stem Cell affiliates involve human cell; tissue, or cellular or tissue-based products (HCT/Ps) subject to FDA regulation; that the company lacks the biologics license required to lawfully market a drug that is also a biological product; and that the company does not have an investigational new drug (IND) application; but in effect that would permit distribution of such products for clinical use while they are in the development stage.
Noting the variety of serious or life-threatening diseases or conditions R3 products are marketed to treat, the agency comments, “Such unapproved uses raise potential significant safety concerns.” The treatment targets mentioned in the letter include dementia, Parkinson’s disease, stroke, ALS, type 1 and type 2 diabetes, kidney failure, Lyme disease, rheumatoid arthritis, spinal stenosis, and trigeminal neuralgia.
Higher risk routes of administration
The letter raises additional safety concerns linked to the way these stem cell products are used: “Additionally, because the products are administered by various higher risk routes of administration, including IV, their use, if contaminated could cause a range of adverse events.” The letter emphasizes that Greene and R3 Stem Cell “are responsible for ensuring that all your products fully comply with the PHS and FD&C [Federal Food, Drug, and Cosmetic] Acts and all applicable regulations.”
Greene said, “Considering that we just received a letter yesterday, it’s too early to make any comments. Our legal team is reviewing the substance of the FDA’s letter and we will be making appropriate revisions to our policies and procedures as necessary based on their recommendations. I would be happy to comment once our legal team has digested the letter and come back with their recommendations.” The FDA has recently increased its enforcement actions against companies marketing unapproved treatments, including US Stem Cell Clinic LLC, California Stem Cell Treatment Centers Inc, and Cell Surgical Network Corporation.