Stem Cell Clinic Loses Appeal to Run Without FDA Oversight (2)

June 2, 2021, 4:17 PMUpdated: June 2, 2021, 10:33 PM

A stem cell clinic effectively shut down by the FDA after several patients went blind lost an appeal to resume a fat-tissue treatment, giving the agency a stronger leg to exert its oversight power.

The U.S. Court of Appeals for the Eleventh Circuit on Wednesday upheld a lower court ruling that U.S. Stem Cell Clinic LLC can’t offer a procedure repurposing fat tissue into stem cells to purportedly treat chronic conditions until it shows the Food and Drug Administration the therapy is safe and effective.

“This decision, affirming the district court’s earlier decision, is a victory for FDA’s work to ...

To read the full article log in.

Learn more about a Bloomberg Law subscription.