Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease

This trial evaluates Stempeucel®, a stem cell therapy derived from human bone marrow, in patients with critical limb ischemia due to atherosclerotic peripheral arterial disease (PAD) — a condition where narrowed arteries severely restrict blood flow to the legs, causing painful ulcers and threatening amputation. The study focuses specifically on patients who are not candidates for, or have already failed, surgical or angioplasty-based revascularization. Eligible participants are aged 18–65, diagnosed with atherosclerotic PAD, not eligible for or have failed revascularization procedures, have at least one leg ulcer between 0.5–10 cm², and have severely reduced ankle-brachial pressure index (≤0.6). Patients with Buerger's disease, those still eligible for surgery, or those in a recent stem cell trial are excluded. Participants receive Stempeucel® injections into the affected limb and are monitored for ulcer healing, pain reduction, and limb salvage outcomes. This trial is critically important because patients with "no-option" critical limb ischemia face very high amputation rates with no effective treatments currently available, and a safe, effective cell therapy could be life-changing for this population.