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Honubicistmut-L (CLBS12) is an autologous cell therapy consisting of CD34+ hematopoietic stem cells isolated from a patient's own peripheral blood following mobilization with granulocyte-colony stimulating factor (G-CSF). Developed by Caladrius Biosciences (now Lisata Therapeutics), this therapy is designed for its regenerative potential in treating ischemic conditions, primarily critical limb ischemia (CLI) and Buerger's disease. The proposed mechanism of action is the promotion of new blood vessel formation (angiogenesis) in tissues with poor blood supply. The CD34+ cells are administered via intramuscular injection directly into the ischemic limb to improve perfusion and reduce the risk of complications like amputation. The therapy received SAKIGAKE designation in Japan, making it eligible for early conditional approval based on Phase 2 clinical data.
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