Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

Last updated: September 8, 2025
Sponsor: Cell Biopeutics Resources Sdn Bhd
Overall Status: Active - Recruiting

Phase

4

Condition

Peripheral Arterial Occlusive Disease

Claudication

Peripheral Vascular Disease

Treatment

Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells

Clinical Study ID

NCT05854615
CBR-BD-22-003
  • Ages 18-65
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Males or females (willing to use accepted methods of contraception during the courseof 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 toprovide voluntary written informed consent, abide by the study requirements, andagree to return for required follow-up visits

Exclusion

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 therapywithin 3 months

  4. Patients who are unsuitable to participate the clinical trial as determined byinvestigators

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
Phase: 4
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2027

Study Description

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.

Connect with a study center

  • Hospital Canselor Tunku Mukhriz

    Kuala Lumpur, 56000
    Malaysia

    Site Not Available

  • Hospital Canselor Tunku Mukhriz

    Kuala Lumpur 1735161, 56000
    Malaysia

    Active - Recruiting

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