Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Recruiting
Phase 4
Interventional Study
Critical Limb Ischemia
Buerger's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 3 (estimated)
- Sponsor
- Cell Biopeutics Resources Sdn Bhd · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years.
2. Buerger's disease as diagnosed by Shionoya criteria
3. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (bo…
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