FDA Questions Arizona Stem Cell Company

Regulatory NewsRegulatory News
| 31 May 2019 | By Zachary Brennan 

As part of efforts to crack down on companies selling unapproved stem cell products to treat a variety of diseases and conditions, the US Food and Drug Administration (FDA) on Thursday sent an untitled letter to Arizona-based R3 Stem Cell and its more than 50 affiliate centers or clinics.

FDA raises concerns with R3 because its website makes unsubstantiated claims about the stem cell products, which FDA says appear to be human cell, tissue, or cellular or tissue-based products that have not been approved. The company claims the products can help patients with serious diseases, some of which have limited treatment options, such as amyotrophic lateral sclerosis (ALS), diabetes, kidney failure, Lyme disease, Parkinson’s disease and stroke.

“Such unapproved uses raise potential significant safety concerns. 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,” FDA said.

The letter is part of a wider crackdown on dubious stem cell clinics that have cropped up across the US. FDA has issued almost 50 warning and untitled letters to such companies and is involved in two pending court cases.

“We intend to step up our oversight of those sponsors who have not engaged the regulatory process in the proper development of their stem cell products that are regulated as drugs, devices, and/or biological products under the statutes and existing regulations, and whose products create more significant potential risks because of the way that they’re manipulated or delivered,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.

R3 Stem Cell did not respond to a request for comment.

Untitled Letter


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