Using Stempeucel® to treat critical limb ischemia from Buerger's 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 aims to evaluate 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 Buerger's disease. It is a single-arm, open-label feasibility study that will observe the treatment's impact on symptoms, healing rates, and functional outcomes over a period of one year. Patients will receive a specific dosage of stem cells based on their body weight, with multiple injections administered into various muscle points. The study will also monitor for any serious adverse events related to the treatment.

Why it matters

Who can join: the full rules

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

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.