Using stem cells from umbilical cords to treat perianal fistulas in Crohn's disease patients

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 clinical trial aims to evaluate the safety of allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) administered via injection for treating complex perianal fistulas in patients suffering from Crohn's disease. The study will involve five participants who will receive a total of 60 million UC-MSCs injected around the fistula tract over five visits, with intervals of 6 to 12 weeks between injections. The primary objective is to demonstrate safety, while secondary objectives include assessing the efficacy of the treatment in improving fistula complications and promoting healing. Regular follow-up examinations will be conducted to monitor patient progress throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult men and women age 18 years and above.
* Diagnosis of perianal fistulae associated with Crohn's disease refractory to medical therapy.
* Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.
* Fit for surgery.

Exclusion Criteria:

* Informed consent refusal.
* Pregnancy or breastfeeding women.
* Current diagnosis of active cancer or remission for less than 5 years.
* Evidence of active sepsis or significant localised infection.
* Patients with HIV, HBV, HCV or treponema infection, whether active or latent.
* Patients with documented allergies.
* Patients who have received infliximab or any other biologics in the 4 weeks before the cell treatment administration.
* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
* Patients with any other co-morbidity/ co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids).

Where it's running

• University of Malaya Medical Centre
  Kuala Lumpur, Malaysia Recruiting

Study contacts

• Principal investigator: April Camilla Roslani, Prof. Dr. — Department of Surgery, Faculty of Medicine, University of Malaya
• Study coordinator: April Camilla Roslani, Prof. Dr.
• Email: april@ummc.edu.my
• Phone: +603-7949 2050

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.