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
Qualifiers
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
Treatments tested in this trial
- Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
Treatment groups
3 Participants
are divided into 1 treatment groupSponsors and collaborators
Cell Biopeutics Resources Sdn Bhd
Lead sponsor
Stempeutics Research Pvt Ltd
Collaborator
National University of Malaysia
Collaborator
Source ClinicalTrials.gov