Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Recruiting now · Phase 1
Conditions studied: Perianal Fistula Due to Crohn's Disease, Fistula in Ano
In brief
Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).
Key facts
- Study ID
- NCT05039411
- Run by
- CryoCord Sdn Bhd
- People needed
- 5
- Starts
- 2022-03-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University of Malaya Medical Centre — Kuala Lumpur, Malaysia (enrolling)
Full record on ClinicalTrials.gov
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