Using Stempeucel® to treat critical limb ischemia in patients with peripheral arterial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.