Actively Recruiting
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Led by CryoCord Sdn Bhd · Updated on 2025-05-11
5
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
C
CryoCord Sdn Bhd
Lead Sponsor
U
University of Malaya
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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).
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
Research Team
A
April Camilla Roslani, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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