FDA accepts first U.S. quality standard for mesenchymal stromal cells, boosting regenerative medicine reliability.

The FDA has accepted a Device Master File for the "Tasly 3P Characterization of MSCs Assay," establishing the first formal quality control standard for mesenchymal stromal cells in the U.S. The protocol, acknowledged on January 9, 2026, evaluates cell identity, purity, and potency to ensure consistency and safety in MSC-based therapies. This move addresses longstanding variability in cell quality and clinical outcomes, aligning with current science that MSCs work primarily through paracrine signaling. The standard is expected to improve trial reliability, streamline regulatory processes, and boost confidence in regenerative medicine treatments.