Using Stempeucel® to treat critical limb ischemia from Buerger's disease
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
This study is testing whether a stem cell treatment called Stempeucel® can help Malaysian patients with critical limb ischemia from Buerger's disease feel better and heal over a year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cell Biopeutics Resources Sdn Bhd Industry-sponsored |
| Locations | 1 site (Kuala Lumpur) |
| Trial ID | NCT05854615 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of Stempeucel®, a type of stem cell therapy, administered intramuscularly to Malaysian patients suffering from critical limb ischemia (CLI) due to Buerger's disease. It is a single-arm, open-label feasibility study that will observe the treatment's impact on symptoms, healing rates, and functional outcomes over a period of one year. Patients will receive a specific dosage of stem cells based on their body weight, with multiple injections administered into various muscle points. The study will also monitor for any serious adverse events related to the treatment.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-65 with Buerger's disease and at least one ulcer, along with a low Ankle Brachial Pressure Index.
Not a fit: Patients with atherosclerotic peripheral arterial disease or those eligible for surgical revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing and reduce symptoms for patients with critical limb ischemia due to Buerger's disease.
How similar studies have performed: While this approach is innovative, similar studies using stem cell therapies for CLI have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kuala Lumpur
- Hospital Canselor Tunku Mukhriz — Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Hanafiah Harunarashid, MS — National University of Malaysia
- Study coordinator: Jezamine Lim, PhD
- Email: info@cellbiopeutics.com
- Phone: +60176073103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.