Actively Recruiting
A Phase I Study of Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for Perianal Fistulas in Patients With Crohn's Disease
Led by CryoCord Sdn Bhd · Updated on 2025-05-11
5
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety of allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) injected locally to treat complex perianal fistulas in patients with Crohn's disease. This Phase I study aims to demonstrate the safety of these stem cells and assess their effectiveness in improving fistula complications and promoting healing of the external openings. The treatment involves injecting a total of 60 million UC-MSCs around the fistula tract with injections spaced 1 cm apart. Patients receive this dose during up to 5 treatment visits spaced 6 to 12 weeks apart. If complete healing occurs at any point, further stem cell injections may be stopped, but regular follow-up examinations continue until study completion. The procedure includes locating the fistula tract, curettage, closing the internal opening, and injecting the stem cells from the internal orifice toward the external opening. Participants will undergo physical examinations and medical tests throughout the study and follow-up periods, which last approximately 1.5 years. Researchers will monitor safety by tracking treatment-emergent adverse events and measure clinical healing at scheduled visits during the treatment and follow-up phases. The total participant involvement includes up to 5 treatment visits and ongoing monitoring if healing occurs earlier.
CONDITIONS
Brief 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...
- Refusal to provide informed consent
- Pregnancy or breastfeeding women
- Current diagnosis of active cancer or remission for less than 5 years
- Evidence of active sepsis or significant localized 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 treatment
- Patients currently receiving or having received any investigational drug within 1 month prior to enrollment
- Patients with any other co-morbidity or co-pathologies that contraindicate stem cell infusion such as infection or steroid use
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months depending on healing and treatment course
Participants receive local injections of allogeneic human umbilical cord mesenchymal stem cells around the fistula tract to treat perianal fistulas associated with Crohn's disease. Treatment consists of up to 5 injection visits spaced 6 to 12 weeks apart. If the fistula is completely healed during the treatment course, subsequent injections may be discontinued.
Up to 5 injection visits spaced 6 to 12 weeks apart
Duration - Until study completion (approximately 1.5 years total from enrollment)
Participants undergo regular follow-up examinations including physical exams and medical tests after treatment to monitor safety and healing until study completion.
Regular follow-up visits after treatment completion
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.
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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