NCT06568653

Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula

The Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula in Colorectal Surgery Department of Imam Khomeini Hospital Complex: A Non-randomized Clinical Trial.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if human placenta mesenchymal stem cells (MSC)-derived exosomes work to treat complex perianal fistula in adults without Crohn's disease. The safety of this treatment will also be learned. The main questions it aims to answer are: * Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants? * Is treatment with MSC-derived exosomes safe? We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy (surgery to close the fistula) alone to see if MSC-derived exosomes work better to treat complex fistula. Participants will: * Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone. * Visit the clinic the week after surgery and then every 4 weeks for checkups and tests

Conditions

• Fistula Perianal

Interventions

Type	Name	Description
PROCEDURE	exosome	human placenta mesenchymal stem cell-derived exosome
PROCEDURE	routine conventional fistulotomy	routine conventional fistulotomy

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-11-15
• Completion: 2025-02-15
• First posted: 2024-08-23
• Last updated: 2024-08-23