1079-Precision Product Framework for MSC Therapy

This perspective piece argues for a transition from a standardized manufacturing model to a precision product framework in the development of mesenchymal stem/stromal cell (MSC) therapies. The author highlights a critical paradox where regulatory standards prioritize high cell viability, yet therapeutic success in inflammatory diseases often depends on host-mediated clearance of apoptotic cells, a process known as efferocytosis. By recognizing that secretory activity and programmed cell death are complementary mechanisms rather than opposing states, researchers can better match specific cell products to the unique microenvironment of a target disease. The source suggests that addressing donor heterogeneity and refining processing protocols, such as post-thaw recovery periods, will resolve current translational bottlenecks. Ultimately, the text calls for a mechanistic approach to manufacturing that treats different MSC preparations as unique drugs tailored to specific clinical indications.

References:

• Donald G. Phinney, A precision product framework for context-dependent mechanisms of MSC therapy, Cell Stem Cell, 2026