RECRUITINGPhase 4INTERVENTIONAL

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial 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 Peripheral Arterial Disease.

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 peripheral arterial disease. The main questions it aims to answer are: * Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes? * Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial 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 May Be Eligible (Plain English)

Who May Qualify: - Patients between 18-65 years old - Patients diagnosed with atherosclerotic peripheral arterial disease - Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients) - Patients with at least one ulcer (between 0.5 to 10 cm2 size) - Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5) - Patients who are able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations Who Should NOT Join This Trial: - Patients diagnosed with Buerger's disease by Shionoya criteria - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients between 18-65 years old * Patients diagnosed with atherosclerotic peripheral arterial disease * Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients) * Patients with at least one ulcer (between 0.5 to 10 cm2 size) * Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5) * Patients who are able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations Exclusion Criteria: * Patients diagnosed with Buerger's disease by Shionoya criteria * 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

Treatments Being Tested

BIOLOGICAL

Stempeucel®

• 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).

Locations (1)

Hospital Canselor Tunku Mukhriz

Kuala Lumpur, Malaysia