Using Stempeucel® to treat critical limb ischemia in patients with peripheral arterial 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 Peripheral Arterial Disease.
This study is testing if a stem cell treatment called Stempeucel® can help Malaysian patients with critical limb ischemia feel better and heal faster.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cell Biopeutics Resources Sdn Bhd Industry-sponsored |
| Locations | 1 site (Kuala Lumpur) |
| Trial ID | NCT05854641 on ClinicalTrials.gov |
What this trial studies
This study evaluates 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 peripheral arterial disease. It is an observational, practice-based feasibility study that aims to determine if this treatment can alleviate symptoms, enhance healing rates, and improve functional outcomes. Patients will be monitored for one year post-treatment to assess any serious adverse events and overall effectiveness. The study involves a single-arm design with multiple injections based on the patient's body weight.
Who should consider this trial
Good fit: Ideal candidates are Malaysian adults aged 18-65 with atherosclerotic peripheral arterial disease who have not responded to or are not eligible for surgical interventions.
Not a fit: Patients with Buerger's 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 the quality of life for patients with critical limb ischemia by promoting healing and reducing symptoms.
How similar studies have performed: While stem cell therapies are being explored for various conditions, this specific approach is novel and has not been extensively tested in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between 18-65 years old * Patients diagnosed with atherosclerotic peripheral arterial disease * Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients) * Patients with at least one ulcer (between 0.5 to 10 cm2 size) * Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5) * Patients who are able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations Exclusion Criteria: * Patients diagnosed with Buerger's disease by Shionoya criteria * Patients eligible for surgical or percutaneous revascularization * Patients with a history of participating in another stem cell trial or therapy within 3 months * 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.