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Clinical Trials/NCT06568653
NCT06568653
Not yet recruiting
Phase 2

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.

Tehran University of Medical Sciences0 sites40 target enrollmentSeptember 15, 2024

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Fistula Perianal
Sponsor
Tehran University of Medical Sciences
Enrollment
40
Primary Endpoint
The number of fistula openings (orifices) will be assessed before and after our intervention.
Status
Not yet recruiting
Last Updated
last year

Overview

Brief 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
Registry
clinicaltrials.gov
Start Date
September 15, 2024
End Date
February 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • participants with complex perianal fistula
  • provided written informed consent

Exclusion Criteria

  • participants with any inflammatory bowel diseases
  • pregnant or lactating participants
  • participants with contraindications for surgery
  • participants with hepatitis
  • participants with uncontrolled diabetes
  • participants with alcohol or substance abuse

Outcomes

Primary Outcomes

The number of fistula openings (orifices) will be assessed before and after our intervention.

Time Frame: 3 months

clinical improvement

Secondary Outcomes

  • QoL questionnaire(3 months)

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