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
| Registry | NCT05854615 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 3 (Estimated) |
| Sponsor | Cell Biopeutics Resources Sdn Bhd (Industry); collaborators: Stempeutics Research Pvt Ltd, National University of Malaysia |
| Conditions | Critical Limb Ischemia, Buerger's Disease |
| Interventions | Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells (Biological) |
| Dates | start 2024-01-01, primary completion 2027-10-01 (estimated), completion 2027-12-01 (estimated), first posted 2023-05-11, last updated 2025-09-09 |
| Locations | 1 site in Malaysia |
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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.
Title: 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
Study Design: Single arm, practice-based, feasibility study
Study Duration: Estimated duration for the main protocol (e.g. from starts of screening to last subject processed and end of the study) is approximately 18 months
Study Center: Universiti Kebangsaan Malaysia Medical Centre (UKMMMC), Jalan Yaacob Latif, Bandar Tun Razak, 56000 Kuala Lumpur, Wilayah Persekutuan, Malaysia
Objectives: To observe the efficacy and safety of Stempeucel® (adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells) in Malaysian patients with critical limb ischemia (CLI) due to Buerger's disease.
Investigational Medicinal Product
Description
• 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).
Dosage • Dosing of Stempeucel® is based on body weight. The recommended dose is 2 million cells/kg body weight.
Administration
• 40 - 60 injections administered as 0.6 ml/kg (200 million bag) or 0.8 ml/kg (150 million bag) intramuscularly into different points on the muscle. Additional injections of 2 ml (200 million bag) or 3 ml (150 million bag) administered around the ulcer
Number of Subjects 3 patients
Data Analysis
Data Management:
* Electronic case record form (eCRF) will be used for data entry.
* Oracle clinical (or other suitable alternatives with audit trail) will be used for data management.
Statistical Method:
* The SPSS® package (IBM Inc., USA, version 22) will be used for statistical evaluation.
* All patients in the study with relevant efficacy and safety data will be considered for the analysis.
* Efficacy analysis will be done using GEE (Generalized Estimating Equations) method or paired t test as appropriate.
* Adverse events monitored using information voluntarily disclosed by the patients and as observed by the PI will be summarized descriptively by total number of AE(s).
* AEs will be categorized as: all AEs, all treatment-emergent AEs, all severe AEs, treatment-related AEs and severe treatment-related AEs. These events will be reported as appropriate and summarized.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Stempeucel® | Experimental | Biological: Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells | Stempeucel® (Ex-vivo cultured MSCs) supplied in 15 ml cryo bags consisting of 200 million or 150 million MSCs, 85% PlasmaLyte-A, 5% HSA and 10% DMSO in a total volume of 15 ml. Following thawing, 35 ml of PlasmaLyte A will be added to the Stempeucel® to make a total volume of 50 ml. The final concentration of components will be 1.5% HSA and 3% DMSO. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: 1. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years. 2. Buerger's disease as diagnosed by Shionoya criteria 3. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (both inclusive) 4. 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 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 Criteria: 1. Patients diagnosed with atherosclerotic peripheral arterial disease 2. Patients eligible for surgical or percutaneous revascularization 3. Patients with a history of participating in another stem cell trial or therapy within 3 months 4. Patients who are unsuitable to participate the clinical trial as determined by investigators
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Canselor Tunku Mukhriz | Kuala Lumpur | Malaysia | Recruiting |