A for-profit stem cell company can’t treat anymore patients with a fat-tissue treatment linked to blindness until it complies with FDA regulations, a federal judge said.
The June 25 order is the second victory for the Food and Drug Administration in three weeks in its effort to prevent clinics from offering experimental therapies to treat a variety of conditions without following the agency’s cell and tissue regulations. It was issued by Judge Ursula Ungaro of the U.S. District for the Southern District of Florida.
The treatment uses a patient’s fat cells and reprocesses them into stem cells. Several patients went ...