An editorial published recently in the Aesthetic Surgery Journal calls for the FDA to expedite its oversight of companies and clinics offering stem-cell products and therapies.
Aesthetic Surgery Journal is the clinical, peer-reviewed journal of the American Society for Aesthetic Plastic Surgery (ASAPS/The Aesthetic Society.
Stem-cell technology, a compelling area of medical research, is widely accepted in therapies for cancer and blood disorders (with clinical trial evidence suggesting stem cells might speed wound healing, improve heart function, and treat scleroderma). Most applications are still in the early stages of being assessed for benefits, limitations, and safety.
Yet, in the last decade many new manufacturers of stem cell products have come into existence, and a huge number of clinics offering stem-cell therapies have opened their doors to eager medical consumers as well as those seeking cosmetic solutions. The most frequent complications of cosmetic stem-cell treatments appear to be contamination and infection, a media release from ASAPS explains.
“We are not in favor of overzealous regulation, but the fact is, organized medicine on its own isn’t equipped to monitor and prevent abuses involving cellular-based treatments,” states Robert Singer, MD, FACS, past-president of ASAPS and an author of the study. “Any procedure marketed in the cosmetic arena holds immense interest to consumers and a high risk for patient abuse,” he explains, in the release.
The FDA announced a regulatory framework in 2017 giving cellular-based treatment clinics and companies 36 months to comply. To better protect public safety while allowing legitimate research to continue, the multi-specialty stem-cell task force recommends:
- Enlisting the help of national surgical-facility-accrediting agencies that already have useful systems in place for monitoring safety
- Collaborating more aggressively with state legislatures and medical boards on related issues such as medical scope of practice
- Requesting support from the Federal Trade Commission to stop false and misleading advertising regarding cellular-based therapies
Organized plastic surgeons are eager to cooperate with the FDA to work toward advancing stem-cell science while protecting the safety and welfare of patients, the release concludes.
[Source(s): ASAPS, PR Newswire]