NCT05039411RecruitingPhase 1
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
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
Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 1 Sept 2021
- Start date
- 1 Mar 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- CryoCord Sdn Bhd
- Diseases
- Crohn's disease
- NCT number
- NCT05039411
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 5
- From 1 Mar 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- Informed consent refusal.
- Pregnancy or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.