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Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
Sponsor: Tehran University of Medical Sciences
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
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-09-15
Completion Date
2025-02-15
Last Updated
2024-08-23
Healthy Volunteers
No
Conditions
Interventions
exosome
human placenta mesenchymal stem cell-derived exosome
routine conventional fistulotomy
routine conventional fistulotomy