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

NCT05854615 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-09

No results posted yet for this 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.

Conditions

  • Critical Limb Ischemia
  • Buerger's Disease

Interventions

BIOLOGICAL

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

• 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).

Sponsors & Collaborators

  • Stempeutics Research Pvt Ltd

    collaborator INDUSTRY

  • National University of Malaysia

    collaborator OTHER

  • Cell Biopeutics Resources Sdn Bhd

    lead INDUSTRY

Principal Investigators

  • Hanafiah Harunarashid, MS · National University of Malaysia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05854615 on ClinicalTrials.gov