(F1290) VERIFICATION OF TISSUE REGENERATION EFFECTS IN A HIND LIMB ISCHEMIA AND SKIN ULCER MODEL MOUSE USING NOVEL CELL THERAPY WITH EX VIVO CULTURED PERIPHERAL BLOOD MONONUCLEAR CELLS
Abstract: We conducted clinical research on cell transplantation therapy using ex vivo expanded human peripheral blood mononuclear cells (MNCQQ) for intractable limb ulcer diseases, confirming safety and efficacy as a vascular regeneration therapy. We have now established a new pharmaceutical-grade cell type, RE01, which overcomes patient variability, allows simpler cultivation, and shows higher angiogenic and wound healing effects than MNCQQ cells. Our non-clinical research with RE01 cells verified therapeutic effects in mouse models of limb ischemia and skin ulcers. In the limb ischemia model, we ligated the femoral artery, administered cells intramuscularly, and observed blood flow changes and limb necrosis over time. For the skin ulcer model, we created ulcers on mice backs, administered cells subcutaneously, and measured ulcer reduction rates. Results revealed significantly enhanced vascular and tissue regeneration in ischemic tissue. RE01 cells represent an innovative peripheral blood cell therapy. We are conducting an investigator-initiated clinical trial for patients with Buerger's disease and collagen disease-derived lower limb ischemic ulcers, aiming to provide a minimally invasive, safe, and effective vascular regeneration therapy. RE01 cells offer a more reliable and potentially more effective treatment option, particularly beneficial for conditions traditionally difficult to treat. Positive preclinical results provide a strong foundation for ongoing clinical trials. If results translate to human patients, RE01 cell therapy could offer new hope for chronic limb ischemia and non-healing ulcers. Potential regulatory approval of RE01 cells as a regenerative medicine product could significantly impact vascular medicine, providing a standardized autologous cellular therapy option. This could improve accessibility and consistency of treatment worldwide. Future research will focus on investigating RE01 cells' therapeutic mechanisms, potentially leading to therapy optimizations and new applications in regenerative medicine. The development and clinical testing of RE01 cells represent a significant advancement in regenerative medicine for vascular diseases, with the potential to revolutionize treatment of limb ischemia and chronic wounds.
