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

NCT06568653 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-23

No results posted yet for this study

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

PROCEDURE

exosome

human placenta mesenchymal stem cell-derived exosome

PROCEDURE

routine conventional fistulotomy

routine conventional fistulotomy

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2024-11-15
Completion
2025-02-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568653 on ClinicalTrials.gov