FDA Accepts Tasly's Device Master File, Setting First Quality Control Standard For MSCs

(RTTNews) - Tasly announced that, in a landmark move for the cell therapy industry, the U.S. Food and Drug Administration has accepted a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal Stromal Cells (MSCs). The FDA's Master File acknowledgement letter, issued on January 9, 2026, incorporates the Tasly 3P Characterization of MSCs Assay (MF 32345) into its regulatory framework. This milestone provides long-sought guidance to ensure the consistent, safe, and effective clinical use of MSCs.

Historically misclassified as stem cells, MSCs have been linked to variable clinical outcomes due to the absence of specific quality benchmarks. The newly recognized "3P" assay addresses this challenge by evaluating three core attributes: Property (cell identity), Purity (freedom from contaminants), and Potency (functional activity). By focusing on these attributes, the assay ensures that therapeutic MSC products are accurately defined, free of heterogeneous cell populations, and biologically potent, Tasly said.

According to the company, the introduction of the Tasly 3P assay marks a pivotal shift toward standardized characterization of MSCs. It mitigates historical risks such as tumor formation and therapeutic inconsistency, while empowering clinicians and patients to verify cell quality before treatment. As the first FDA-recognized protocol of its kind, the assay sets a new benchmark for the field and accelerates the transition in regenerative medicine from a stem-cell-centric model to a stromal cell-focused paradigm.

On Monday, Tasly Pharmaceutical Group Co., Ltd. (600535.SS) traded at CNY 15.23 in Shanghai as of 9:39 AM GMT+8, down 0.02 yuan or 0.13%.

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