FDA issues warning to stem cell company promoting unapproved stroke therapies

Arizona-based R3 Stem Cell, LLC is under fire this week after the FDA sent the company an untitled, three-page letter detailing significant shortcomings in their process.

The Scottsdale company promotes what they call “regenerative stem cell therapies” for a host of conditions, including dementia, Parkinson’s disease, rheumatoid arthritis and spinal stenosis. In her May 28 letter, FDA Director of the Office of Compliance and Biologics Quality Mary A. Malarkey accused R3 of directing patients with diseases like amyotrophic lateral sclerosis, diabetes, kidney failure, Lyme disease and stroke to their “R3 Stem Cell Centers of Excellence” for treatment even though none of R3’s products or sites have been FDA-approved.

Malarkey pointed out the company’s referenced stem cell therapies are all human cell, tissue, or cellular or tissue-based products (HCT/Ps), which are subject to regulation under 21 CFR Part 1271. HCT/Ps that don’t meet all criteria under that regulation and don’t quality for an exception are additionally regulated as drugs, devices or biological products and face further scrutiny.

“Based on a review of your website, it appears that R3 Stem Cell, LLC does not qualify for any exception in 21 CFR 1271.15 and the stem cell therapies offered by R3 Stem Cell, LLC are intended for nonhomologous uses and would be regulated as drugs as defined in section 201(g) of the FD&C Act,” Malarkey wrote. “In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect. Such licenses are issued only after a demonstration that the product is safe, pure and potent.”

Such products can be distributed for clinical use in humans in their development stage, Malarkey said, but only if the sponsor has an FDA-regulated investigational new drug application already in effect.

The FDA said R3’s practices could be dangerous for patients with life-threatening conditions, especially since the stem cell therapies can be administered in risky ways, like through IV. The agency said the company will be responsible for ensuring all their products fully comply with applicable acts and regulations.