Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's… (NCT05854615) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Malaysia3 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
âś“. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years.
âś“. Buerger's disease as diagnosed by Shionoya criteria
âś“. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (both inclusive)
✓. Ankle Brachial Pressure Index (ABPI) ≤ 0.6. If ABPI is ≥ 1.1 then Toe Brachial Index (TBI) will be performed and TBI should be ≤ 0.5
âś“. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits
Exclusion criteria
âś•. Patients diagnosed with atherosclerotic peripheral arterial disease
âś•. Patients eligible for surgical or percutaneous revascularization
âś•. Patients with a history of participating in another stem cell trial or therapy within 3 months
What they're measuring
1
Change in ischemic rest pain
Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360
2
Change in size of the ulcer
Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360
3
Change in ankle brachial pressure index (ABPI)
Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360
4
Change in total walking distance
Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360
5
Change in major amputation-free survival
Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360