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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 2024 to Oct 2027
    • Study completion date: Dec 2024 to Dec 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2023 to Jan 1, 2024
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05854615
Lead Sponsor Cell Biopeutics Resources Sdn Bhd
Collaborators: Stempeutics Research Pvt Ltd, National University of Malaysia
Conditions
(from sponsor)		 Critical Limb Ischemia, Buerger's Disease
Related terms Chronic Limb-Threatening Ischemia, Thromboangiitis Obliterans
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov