Phase 4 Vasculitis Trial, Recruiting NCT05854615 Sponsor: Cell Biopeutics Resources Sdn Bhd Condition: Vasculitis
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Phase 4 Vasculitis Trial, Recruiting

NCT05854615
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a man or woman aged between 18 and 65 years old, and if you could become pregnant, you are willing to use an accepted form of birth control during the study
  • You have been diagnosed with Buerger's disease (a condition affecting blood vessels) using a specific set of recognised diagnostic guidelines called the Shionoya criteria
  • You have at least one wound or ulcer of a specific size — between 0.5 and 10 square centimetres
  • Your blood flow to your feet and ankles is below a certain level, as measured by standard circulation tests (confirm with trial site for exact test details)
  • You are able to understand what the study involves, are willing to sign a consent form, follow the study rules, and attend all required follow-up appointments

Who may not be able to join:

  • You have been diagnosed with a different type of blood vessel disease caused by fatty deposits in the arteries (known as atherosclerotic peripheral arterial disease)
  • You are considered suitable for a surgical procedure or a minimally invasive procedure to restore blood flow to your limbs
  • You have taken part in another stem cell trial or received stem cell therapy within the last 3 months
  • The medical team running the trial decides for any reason that it would not be appropriate for you to participate (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Hanafiah Harunarashid, MS, National University of Malaysia

Phone: +60176073103

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Cell Biopeutics Resources Sdn Bhd
Registry
ClinicalTrials.gov
Start date
1 January 2024
Est. completion
1 October 2027

Where this trial is recruiting

🇲🇾 Malaysia

Primary endpoints

Change in ischemic rest pain; Change in size of the ulcer; Change in ankle brachial pressure index (ABPI); Change in total walking distance; Change in major amputation-free survival; Change in angiogenesis

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov