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

August 22, 2024 updated by: Tehran University of Medical Sciences

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.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
Procedure: routine conventional fistulotomy
routine conventional fistulotomy
Experimental: intervention
Procedure: exosome
human placenta mesenchymal stem cell-derived exosome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of fistula openings (orifices) will be assessed before and after our intervention.
Time Frame: 3 months
clinical improvement
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL questionnaire
Time Frame: 3 months
quality of life improvement (before and after intervention) assessed by Persian (Farsi) version of the QoLAF (quality of life in patients with anal fistula) questionnaire
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2024

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.TUMS.IKHC.REC.1403.113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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