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Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease

RecruitingPhase 4Ages 18 Years - 65 YearsAllCell Biopeutics Resources Sdn Bhd
NCT05854641 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 peripheral arterial disease. The main questions it aims to answer are: * Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes? * Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial 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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Stempeucel®
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Where

1 site
Hospital Canselor Tunku Mukhriz
Kuala Lumpur, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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