Safety of Stem Cell Injections for Crohn's Disease Perianal Fistulas
Tests umbilical cord stem cell injections in adults with Crohn's-related perianal fistulas.
Plain-language title generated from the registry record
Registry title: Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Key facts
- Where
- Kuala Lumpur, MalaysiaSee the site
- Phase
- Phase 1
Where in Malaysia
- University of Malaya Medical CentreKuala Lumpur, MalaysiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CryoCord Sdn Bhd
- Trial code
- NCT05039411
- Record updated
- 11 May 2025
- Original description
Objectives:Read full original descriptionShow less
A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease
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).
Inclusion: 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: 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; 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 with any other co-morbidity/ co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids); Informed consent refusal; Pregnancy or breastfeeding women.