Using stem cells from umbilical cords to treat perianal fistulas in Crohn's disease patients
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
This study is testing if injections of stem cells from umbilical cords can safely help people with Crohn's disease heal complex perianal fistulas.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CryoCord Sdn Bhd Industry-sponsored |
| Drugs / interventions | infliximab |
| Locations | 1 site (Kuala Lumpur) |
| Trial ID | NCT05039411 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) administered via injection for treating complex perianal fistulas in patients suffering from Crohn's disease. The study will involve five participants who will receive a total of 60 million UC-MSCs injected around the fistula tract over five visits, with intervals of 6 to 12 weeks between injections. The primary objective is to demonstrate safety, while secondary objectives include assessing the efficacy of the treatment in improving fistula complications and promoting healing. Regular follow-up examinations will be conducted to monitor patient progress throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with perianal fistulas related to Crohn's disease that have not responded to conventional medical therapies.
Not a fit: Patients who are pregnant, breastfeeding, or have active infections or certain co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients with complex perianal fistulas associated with Crohn's disease.
How similar studies have performed: While the use of UC-MSCs in treating perianal fistulas is a relatively novel approach, similar studies involving stem cell therapies have shown promising results in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Kuala Lumpur
- University of Malaya Medical Centre — Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: April Camilla Roslani, Prof. Dr. — Department of Surgery, Faculty of Medicine, University of Malaya
- Study coordinator: April Camilla Roslani, Prof. Dr.
- Email: april@ummc.edu.my
- Phone: +603-7949 2050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.