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This autologous cell therapy is being developed by the Royan Institute for Stem Cell Biology and Technology for the treatment of critical limb ischemia (CLI) and advanced chronic lower limb ischemia. The treatment involves the extraction of mononuclear cells from the patient's own bone marrow (BM-MNCs), which are then processed and injected directly into the affected ischemic limb. The therapeutic approach relies on regenerative medicine and therapeutic angiogenesis; the transplanted cells are thought to secrete various pro-angiogenic growth factors and cytokines that stimulate the formation of new blood vessels and improve blood perfusion in oxygen-deprived tissues. Clinical studies, including Phase 1/2 trials, have evaluated the safety and efficacy of these cell injections, sometimes in conjunction with granulocyte colony-stimulating factor (G-CSF) to enhance the mobilization or therapeutic potential of the cells.
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