Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

This study tests Stempeucel®, a bone marrow-derived stem cell therapy, in patients with critical limb ischemia caused by Buerger's disease — a rare inflammatory condition that blocks blood flow to the arms and legs, typically in younger smokers. When blood flow becomes severely restricted, patients develop painful ulcers, risking amputation. This trial aims to see whether injecting these stem cells can stimulate new blood vessel growth and heal these wounds. Eligible participants are men or women aged 18–65 diagnosed with Buerger's disease (by Shionoya criteria) who have at least one ulcer between 0.5 and 10 cm², and an ankle-brachial pressure index of 0.6 or less indicating severely reduced blood flow. Patients with atherosclerotic peripheral artery disease, those eligible for bypass surgery, or those who have participated in another stem cell trial within the past 3 months are excluded. Participants receive Stempeucel® injections and are followed for wound healing, limb salvage, and blood flow measures. This research is significant because Buerger's disease has no approved disease-modifying treatment, and stem cell therapy represents a promising strategy to save limbs in patients who otherwise face amputation.