autologous bone marrow mononuclear cells (FOSCAL)

Autologous bone marrow mononuclear cell (auto-BM-MNC) therapy is an investigational cell-based biologic developed by the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle (FOSCAL) for the treatment of chronic limb-threatening ischemia (CLTI), specifically in diabetic patients. The therapy utilizes the patient's own bone marrow-derived mononuclear cells, which are harvested and then injected into the periadventitial layer of the arterial walls in the affected limb. This regenerative approach is intended to stimulate angiogenesis and improve blood flow in patients who are not candidates for standard surgical or endovascular revascularization. In a Phase 1/2 clinical trial (NCT05631444), the therapy demonstrated a 100% limb preservation rate over 12 months in the treatment group compared to 60% in the placebo group, alongside improvements in quality of life.

Other names

auto-BM-MNCautologous bone marrow mononuclear cell therapy