RecruitingPhase 4

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

Malaysia10 participantsStarted 2024-01-01

Plain-language 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 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in ischemic rest pain

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in size of the ulcer

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in ankle brachial pressure index (ABPI)

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in total walking distance

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in major amputation-free survival

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in angiogenesis

Timeframe: Screening (Day -14 to -1), Day 180

Trial details

NCT IDNCT05854641

SponsorCell Biopeutics Resources Sdn Bhd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Jezamine Lim, PhD

+60176073103 info@cellbiopeutics.com

View on ClinicalTrials.gov More Critical Limb Ischemia trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in ischemic rest pain

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in size of the ulcer

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in ankle brachial pressure index (ABPI)

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in total walking distance

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in major amputation-free survival

Timeframe: Screening (Day -14 to -1), Day 30, 90, 180 and 360

Change in angiogenesis

Timeframe: Screening (Day -14 to -1), Day 180