Observing Safety and Effectiveness of Stempeucel4 Treatment by Injection in Malaysian Adults With Critical Limb Ischemia Caused by Peripheral Arterial Disease

What this Trial Is About

Researchers are evaluating the effectiveness and safety of intramuscular administration of Stempeucel4, a type of cultured mesenchymal stem cell treatment, in Malaysian patients with critical limb ischemia CLI caused by peripheral arterial disease. This observational, practice-based feasibility study aims to see if Stempeucel4 can reduce CLI symptoms, improve healing and functional outcomes, and determine if it causes any serious side effects. The study will follow patients for up to one year after treatment for safety and efficacy assessment. Participants will receive Stempeucel4, which consists of ex-vivo cultured allogeneic mesenchymal stem cells provided in cryo-bags containing 150 or 200 million cells suspended in Plasmalyte A solution. The dose is based on body weight at 2 million cells per kilogram. The treatment involves 40 to 60 intramuscular injections into different muscle points and additional injections around ulcers. The study includes about 10 patients and uses electronic data systems to collect and analyze safety and effectiveness data. During the study, patients will undergo assessments at screening and on days 30, 90, 180, and 360. These assessments include measuring pain levels at rest, ulcer size, ankle brachial pressure index, walking distance, amputation-free survival, and angiogenesis. Safety monitoring includes checking adverse events, laboratory tests, vital signs, physical exams, ECGs, and chest conditions. The total study duration is approximately 18 months, and data will be analyzed using statistical methods to evaluate outcomes.

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