Stem cell treatment: FDA court victory opens way to regulation in USBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l4128 (Published 07 June 2019) Cite this as: BMJ 2019;365:l4128
- Owen Dyer
Companies that offer treatments in the US that are based on mesenchymal stem cells derived from human fat are likely to face effective regulation by the Food and Drug Administration for the first time, after the agency’s groundbreaking court victory over one of the best known practitioners, US Stem Cell Clinic.
The industry has long argued that, because it uses cells taken from the patient’s own body, its treatments were not drugs and shouldn’t be regulated by the FDA. But the agency contended that the extensive processing of patients’ adipose tissue after its removal from the body made it an “adulterated” product in need of oversight.
Although further appeals are still possible, for now at least US District Judge Ursula Ungaro of the Southern District of Florida seems to have settled that argument decisively in the government’s favour. …