FDA’s Biologics Branch Scores Wins Against Unproven Stem Cell Clinics, Says Expert

Professor Paul Knoepfler, a cell‑biology professor at UC Davis, writes that the FDA’s biologics division has recently taken concrete steps to curb the proliferation of unproven stem‑cell clinics in the United States.

He references a 2025 interview with health secretary Robert F. Kennedy Jr., who disclosed receiving unapproved stem‑cell treatments abroad, raising fears that similar U.S. clinics might evade oversight.

Knoepfler notes that, despite a politically charged regulatory environment, the agency has achieved two notable science‑based actions against these clinics, which he describes as surprising and worth celebrating.

The piece underscores the broader problem of more than 2,000 questionable stem‑cell firms operating nationwide and suggests that the FDA’s recent moves represent a bright spot in an otherwise challenging landscape.