Stem cell clinic crackdown continues with FDA letter to R3

Despite receiving an untitled letter from the US FDA over its promotion of unapproved stem cell therapies, Arizona firm R3 Stem Cell, LLC continues to push its questionable therapies to “vulnerable patients.”

The US Food and Drug Administration (FDA) has put Scottsdale, Arizona-based company R3 Stem Cell on notice for marketing unapproved stem cell treatments.

In the untitled letter dated May 30, the Agency said R3, through its affiliated clinics, offers unapproved stem cell products for serious conditions including Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS).

“It appears that the products offered by the company would be regulated as drugs and biological products under the Federal Food Drug and Cosmetic Act and the Public Health Service Act,” the letter states.

“Prior to marketing, such products require a demonstration that the products are safe and effective for their intended uses. Manufacturers who fail to comply with FDA requirements may be subject to enforcement action, such as seizure, injunction, or prosecution.”

Clampdown and comment

Initiated by former commissioner Scott Gottlieb, the FDA has become proactive over the past few years in its efforts to clampdown on stem cell “bad actors.”

Part of the email sent as a response to questions asked about the FDA’s untitled letter

The Agency has issued warning letters and seized unapproved products made by stem cell clinics, and the untitled letter to R3 is the latest example.

“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products. The reality is that at this time, there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system,” FDA acting commissioner Ned Sharpless said in the letter.

Bioprocess Insider contacted R3 for comment on the back of the FDA notification, first by automated chat and then through email.

Instead of comment, R3 thanked this journalist for “inquiring about regenerative treatment at an R3 Stem Cell Center of Excellence,” and offered me stem cell products “under IRB Approved Protocols for all types of musculoskeletal, systemic and neurologic conditions” including the conditions highlighted by the FDA.

“Whether you are an athlete [definitely not], grandparent [a good few years off], fighting a chronic disease [hopefully not], or simply trying to avoid a joint replacement or dialysis [simply nope], let us help you,” the firm said in its email response.