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

Phase 2

Not yet recruiting

• Conditions: Fistula Perianal
• Interventions: Procedure: routine conventional fistulotomy; Procedure: exosome

• Registration Number: NCT06568653
• Lead Sponsor: Tehran University of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Study Start: 2024-09-15
• Primary Completion: 2024-11-15
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	routine conventional fistulotomy	-
intervention	exosome	-

Primary Outcome Measures

Name	Time	Method
The number of fistula openings (orifices) will be assessed before and after our intervention.	3 months	clinical improvement

Secondary Outcome Measures

Name	Time	Method
QoL questionnaire	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