Actively Recruiting
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Led by Cell Biopeutics Resources Sdn Bhd · Updated on 2025-09-09
3
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
C
Cell Biopeutics Resources Sdn Bhd
Lead Sponsor
S
Stempeutics Research Pvt Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 65 years who agree to use contraception during the study
- Diagnosis of Buerger's disease by Shionoya criteria
- At least one target ulcer with an area between 0.5 to 10 cm2
- Ankle Brachial Pressure Index (ABPI) of 0.6 or less, or if ABPI is 1.1 or higher, Toe Brachial Index (TBI) of 0.5 or less
- Ability to understand study requirements, provide written informed consent, and agree to follow-up visits
You will not qualify if you...
- Diagnosis of atherosclerotic peripheral arterial disease
- Eligible for surgical or percutaneous revascularization
- Participation in another stem cell trial or therapy within the last 3 months
- Determined unsuitable for the clinical trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Canselor Tunku Mukhriz
Kuala Lumpur, Malaysia, 56000
Actively Recruiting
Research Team
J
Jezamine Lim, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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