Actively Recruiting
Phase 1 Study of Safety of Umbilical Cord Stem Cell Injections for Treating Perianal Fistulas in Crohns Disease Patients
Led by CryoCord Sdn Bhd · Updated on 2025-05-11
5
Participants Needed
1
Research Sites
N/A
Total Duration
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 Crohns 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
Research Team
A
April Camilla Roslani, Prof. Dr.
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