FDA accepts first quality control protocol for Mesenchymal Stromal Cells; sets new therapeutic standard. (Characters: 108)

In an unprecedented development in the cell therapy sector, a Device Master File (DMF) outlining the pioneering quality control standard for Mesenchymal Stromal Cells (MSCs) has been approved by the U.S. Food and Drug Administration (FDA). This milestone achievement emerged from TIANJIN, China, on January 25, 2026. This crucial step sets a significant precedent for the industry, as it marks the initial establishment of a defined quality benchmark for MSCs in medical applications. This move emphasizes the increasing focus on standards and regulations to ensure the effectiveness and safety of cellular therapies.