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

Recruiting now · Phase 4

Conditions studied: Critical Limb Ischemia, Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT05854641

Run by

Cell Biopeutics Resources Sdn Bhd

People needed

10

Starts

2024-01-01

Expected to finish

2027-12-01

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Hospital Canselor Tunku Mukhriz — Kuala Lumpur, Malaysia (enrolling)

Full record on ClinicalTrials.gov

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