Unregulated Stem Cell Clinics Selling Unapproved Therapies in the United States

At least 351 companies in the United States are marketing unapproved stem cell procedures – for osteoarthritis, Alzheimer’s disease, autism, spinal cord injuries, and cosmetic enhancements, among others – at 570 clinics across the country, according to a report published in Cell Stem Cell.

The researchers identified these businesses through internet keyword searches, text mining, and content analysis of company websites. For each business, they recorded the company name, location(s), website addresses, advertised stem cell types, and marketing claims concerning diseases, injuries, and conditions for which stem cells are reportedly administered.

Most of the clinics were found in California (n=113), Florida (n=104), and Texas (n=71), and almost two-thirds of the businesses offered procedures involving stem cells derived from a patient’s own fat, while almost half performed treatments using bone marrow.

The U.S. Food and Drug Administration (FDA) has approved only a few stem cell treatments. The researchers noted that many of the procedures being conducted in these clinics are not FDA approved, are outside of any clinical trials, and can cost patients thousands of dollars. Unapproved stem cell therapies also have no conclusive evidence of safety or effectiveness, and receiving unapproved and unproven stem cell interventions can potentially decrease patients’ chances of qualifying for FDA- and institutional review board-approved clinical trials.

It was unclear to the researchers whether federal authorities and state medical boards had missed the scope of the problem or were only taking minimal actions. Stem cell procedures are not heavily regulated because they use cells from a patient’s own body. However, earlier this year, the FDA issued draft guidelines (that will be discussed at a public hearing in September) asserting that stem cells used in most procedures are considered drugs and should require a rigorous approval process prior to use.

Sources: Turner L, Knoepfler P. Selling stem cells in the USA: assessing the direct-to-consumer industry. Cell Stem Cell. 2016;S1934-5909:30157-6; The Washington Post, June 30, 2016; UC Davis Health System news release, June 30, 2016; Reuters, July 4, 2016.