RecruitingPhase 4NCT05854615

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

An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

Sponsor

Cell Biopeutics Resources Sdn Bhd

Enrollment

3 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Buerger's Disease Critical Limb Ischemia

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years.
Buerger's disease as diagnosed by Shionoya criteria
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
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 Criteria4

Patients diagnosed with atherosclerotic peripheral arterial disease
Patients eligible for surgical or percutaneous revascularization
Patients with a history of participating in another stem cell trial or therapy within 3 months
Patients who are unsuitable to participate the clinical trial as determined by investigators

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Interventions

BIOLOGICALAdult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells

• Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in cryo-bags consisting of 150 or 200 million, suspended in 50 ml of Plasmalyte A containing 1.5% human serum albumin (HSA) and 3% dimethyl sulfoxide (DMSO).