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

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

NCT Number	NCT06568653
Lead Sponsor	Tehran University of Medical Sciences
Conditions	Fistula Perianal
Enrollment	40 participants
Start Date	2024-09-15
Primary Completion	2024-11-15 (estimated)
Study Completion	2025-02-15 (estimated)
Updated on ClinicalTrials.gov	2024-08-23