NCT05854615 Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
| NCT ID | NCT05854615 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cell Biopeutics Resources Sdn Bhd |
| Condition | Critical Limb Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3 participants in total. It began in 2024-01-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hanafiah Harunarashid, MS
PRINCIPAL INVESTIGATOR
National University of Malaysia
Frequently Asked Questions
Who can join the NCT05854615 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Critical Limb Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05854615 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05854615 currently recruiting?
Yes, NCT05854615 is actively recruiting participants. Contact the research team at info@cellbiopeutics.com for enrollment information.
Where is the NCT05854615 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia.
Who is sponsoring the NCT05854615 clinical trial?
NCT05854615 is sponsored by Cell Biopeutics Resources Sdn Bhd. The principal investigator is Hanafiah Harunarashid, MS at National University of Malaysia. The trial plans to enroll 3 participants.