Observational Study of Stempeucel Injections for Treating Critical Limb Ischemia Due to Buergers Disease in Malaysian Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intramuscular administration of Stempeucel adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells in Malaysian patients with critical limb ischemia CLI caused by Buergers disease. This observational, practice-based feasibility study aims to see if Stempeucel can reduce CLI symptoms, improve ulcer healing, and enhance functional outcomes while monitoring for any serious adverse events. The treatment involves a single arm where Stempeucel cells are supplied in cryo-bags containing 150 or 200 million cells suspended in a liquid mixture. The dose is based on body weight, with injections administered intramuscularly into various points on the muscles, including additional injections around the ulcer. The study is planned to last approximately 18 months, with treatment and follow-up occurring during this period. Participants will be assessed before treatment and monitored over one year after administration for safety and effectiveness. Evaluations include measurement of ischemic rest pain, ulcer size, ankle brachial pressure index, walking distance, amputation-free survival, and angiogenesis at multiple time points up to 360 days. Safety assessments involve tracking adverse events, laboratory tests, vital signs, physical exams, ECGs, and chest condition, with data recorded electronically for analysis.

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