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.
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)
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
Single group
Stempeucel®
Biological/Vaccine• 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).
Change in ischemic rest pain
Change in visual analog score (VAS) compared to screening
Change in size of the ulcer
Change in size of the ulcer compared to screening
Change in ankle brachial pressure index (ABPI)
Change in ankle brachial pressure index (ABPI) compared to screening
Change in total walking distance
Change in total walking distance on a treadmill compared to screening
The type of AE(s), number of AE(s) and proportion of patients with AE(s)
Monitored and recorded as voluntarily disclosed by the patients and as observed by the Investigator throughout the study
Incidence of abnormal laboratory test results (serum chemistry, haematology, liver function test)
The following lab tests will be conducted: serum chemistry, haematology, liver function test. In case of abnormal results, they shall be recorded as an adverse event or excluded from study (screening).
Incidence of abnormal urine test results
Urine test will be conducted. In case of abnormal results, they shall be recorded as an adverse event or excluded from study (screening).
Incidence of abnormal TNF-α
TNF-α test will be conducted. In case of abnormal results, they shall be recorded as an adverse event or excluded from study (screening).
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Cell Biopeutics Resources Sdn Bhd
Lead sponsor
Stempeutics Research Pvt Ltd
Collaborator
National University of Malaysia
Collaborator
