Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
ID05854615

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 Due to Buerger's Disease

Led by Cell Biopeutics Resources Sdn Bhd · Updated on 2025-09-09

3

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

C

Cell Biopeutics Resources Sdn Bhd

Lead Sponsor

S

Stempeutics Research Pvt Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intramuscular administration of Stempeucel (adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells) in Malaysian patients with critical limb ischemia (CLI) caused by Buerger's disease. This observational, practice-based feasibility study aims to see if Stempeucel can reduce CLI symptoms, improve ulcer healing, and enhance functional outcomes while monitoring for any serious adverse events. The treatment involves a single arm where Stempeucel cells are supplied in cryo-bags containing 150 or 200 million cells suspended in a liquid mixture. The dose is based on body weight, with injections administered intramuscularly into various points on the muscles, including additional injections around the ulcer. The study is planned to last approximately 18 months, with treatment and follow-up occurring during this period. Participants will be assessed before treatment and monitored over one year after administration for safety and effectiveness. Evaluations include measurement of ischemic rest pain, ulcer size, ankle brachial pressure index, walking distance, amputation-free survival, and angiogenesis at multiple time points up to 360 days. Safety assessments involve tracking adverse events, laboratory tests, vital signs, physical exams, ECGs, and chest condition, with data recorded electronically for analysis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 65 years, willing to use accepted contraception during the study
  • Diagnosed with Buerger's disease by Shionoya criteria
  • Have at least one ulcer with area between 0.5 and 10 cm2
  • Ankle Brachial Pressure Index (ABPI) �.6 or less; if ABPI is 1.1 or higher, Toe Brachial Index (TBI) should be 0.5 or less
  • Able to understand study requirements, provide voluntary written consent, and agree to follow-up visits
Not Eligible

You will not qualify if you...

  • Diagnosed with atherosclerotic peripheral arterial disease
  • Eligible for surgical or percutaneous revascularization
  • Participated in another stem cell trial or therapy within the past 3 months
  • Considered unsuitable for the trial by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Single treatment session

Participants receive intramuscular injections of Stempeucel®, a stem cell therapy, administered at multiple muscle sites and around ulcers to treat critical limb ischemia due to Buerger's disease.

1 treatment visit (in-person)

Follow-up

Duration - Up to 12 months post-treatment

Participants attend follow-up visits to monitor efficacy and safety outcomes including pain, ulcer size, ankle brachial pressure index, walking distance, adverse events, and laboratory tests.

Visits on Day 7, 30, 90, 180, and 360 after treatment

Trial Site Locations

Total: 1 location

1

Hospital Canselor Tunku Mukhriz

Kuala Lumpur, Malaysia, 56000

Actively Recruiting

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Research Team

J

Jezamine Lim, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

A phase II trial of autologous transplantation of bone marrow stem cells for critical limb ischemia: results of the Naples and Pietra Ligure Evaluation of Stem Cells study.

Alessandro Schiavetta, Ciro Maione, Chiara Botti...

https://pubmed.ncbi.nlm.nih.gov/23197862

Autologous stem cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature.

Gian Paolo Fadini, Carlo Agostini, Angelo Avogaro

https://pubmed.ncbi.nlm.nih.gov/19740466

Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.

Michael S Conte, Patrick J Geraghty, Andrew W Bradbury...

https://pubmed.ncbi.nlm.nih.gov/19897335

Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization.

William A Marston, Stephen W Davies, Brian Armstrong...

https://pubmed.ncbi.nlm.nih.gov/16828434

Changes in angiogenesis-related factors in serum following autologous bone marrow cell implantation for severe limb ischemia.

Yoshihito Tachi, Daisuke Fukui, Yuko Wada...

https://pubmed.ncbi.nlm.nih.gov/18476781