A seminal research paper in the saga of questionable stem cell medical treatments has just been retracted, largely due to ethical concerns.
The 2017 paper touted the safety of injecting stem cells derived from patients' fat cells into their arthritic knees. It implied that the treatment was successful in its sample of 10 patients.
Its purported conclusions were then broadcast by U.S. Stem Cell, a Florida clinic that has since come under legal fire by the Food and Drug Administration. In 2019, the FDA obtained a permanent injunction from federal court forbidding the firm from continuing its treatments.
The retracted paper was co-written by Kristen Comella, who was then the chief scientific officer of U.S. Stem Cell. The FDA's lawsuit seeking the injunction named Comella as well as the stem cell firm.
Comella left the company in 2019, following the court injunction.
The retraction by the Journal of Translational Medicine underscores the doubts of respected stem cell experts in the efficacy of U.S. Stem Cell's treatments. The clinic's method involved extracting stem cells — known medically as stromal vascular fraction or SVF — from fat removed from patients by liposuction. The stem cells were then injected into the patients at the site of their injuries.
The technique was followed by hundreds of clinics purporting to treat arthritis or other conditions, including diabetes, multiple sclerosis and Parkinson's, through injections of fat-derived stem cells. No solid scientific evidence has ever been published establishing the efficacy of the treatment.
The FDA warns patients against undergoing such "unapproved" treatments for such conditions. The only stem cell treatments approved by the FDA involve the use of umbilical cord-derived cells for the treatment of some blood diseases.
"This retraction just adds further doubt for many of us about the use of SVF for arthritis," wrote stem cell expert Paul Knoepfler of UC Davis, who first pointed us to the retraction notice, on his lab's blog.
The treatment gained notice after it was talked up by professional athletes seeking to alleviate joint pain, including golfer Jack Nicklaus.