drugset / Trial / NCT05854615

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

NCT05854615

NaSingle-groupOpen-labelTreatment

Summary

The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to Buerger's disease. The main questions it aims to answer are: * Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to Buerger's disease while improving the healing rate and functional outcomes? * Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to Buerger's disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.

Timeline

Start
2024-01-01
Primary completion
2027-10
Completion
2027-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Stempeucel® Cell therapy 2 cells/kg Intramuscular