NCT05039411 Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
| NCT ID | NCT05039411 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | CryoCord Sdn Bhd |
| Condition | Perianal Fistula Due to Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5 participants in total. It began in 2022-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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).
Contact & Investigator
April Camilla Roslani, Prof. Dr.
PRINCIPAL INVESTIGATOR
Department of Surgery, Faculty of Medicine, University of Malaya
Frequently Asked Questions
Who can join the NCT05039411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perianal Fistula Due to Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05039411 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05039411 currently recruiting?
Yes, NCT05039411 is actively recruiting participants. Contact the research team at april@ummc.edu.my for enrollment information.
Where is the NCT05039411 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia.
Who is sponsoring the NCT05039411 clinical trial?
NCT05039411 is sponsored by CryoCord Sdn Bhd. The principal investigator is April Camilla Roslani, Prof. Dr. at Department of Surgery, Faculty of Medicine, University of Malaya. The trial plans to enroll 5 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.