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This investigational autologous cell therapy is developed by the Royan Institute for Stem Cell Biology and Technology for the treatment of long bone nonunions, specifically tibia nonunion. The therapy consists of patient-derived bone marrow mesenchymal stromal cells (BM-MSCs) that are expanded in vitro and combined with a platelet lysate (PL) product. Administered percutaneously into the fracture site under fluoroscopic guidance, the MSCs are intended to provide a cellular source for osteogenesis by differentiating into bone-forming cells. The platelet lysate serves as a concentrated source of growth factors that stimulate the proliferation and differentiation of the MSCs, collectively promoting bone regeneration in cases where standard healing has failed.
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