Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCell Biopeutics Resources Sdn Bhd
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 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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
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).
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Stempeucel®Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in ischemic rest pain
Change in visual analog score (VAS) compared to screening
Time frame
Screening (Day -14 to -1), Day 30, 90, 180 and 3602
Change in size of the ulcer
Change in size of the ulcer compared to screening
Time frame
Screening (Day -14 to -1), Day 30, 90, 180 and 3603
Change in ankle brachial pressure index (ABPI)
Change in ankle brachial pressure index (ABPI) compared to screening
Time frame
Screening (Day -14 to -1), Day 30, 90, 180 and 3604
Change in total walking distance
Change in total walking distance on a treadmill compared to screening
Time frame
Screening (Day -14 to -1), Day 30, 90, 180 and 360Secondary outcomes
1
The type of AE(s), number of AE(s) and proportion of patients with AE(s)
AE(s) will be monitored and recorded as voluntarily disclosed by the patients and as observed by the investigator throughout the study
Time frame
Screening (Day -14 to -1)2
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).
Time frame
Screening (Day -14 to -1), Day 7, 30, 90, 180 and 3603
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).
Time frame
Screening (Day -14 to -1), Day 1804
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).
Time frame
Screening (Day -14 to -1), Day 7 and 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cell Biopeutics Resources Sdn Bhd
Lead sponsor
Stempeutics Research Pvt Ltd
Collaborator
National University of Malaysia
Collaborator
Source ClinicalTrials.gov