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

Tehran University of Medical Sciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Fistula Perianal

Treatments: Procedure: routine conventional fistulotomy; Procedure: exosome

Study type: Interventional

Funder types: Other

Identifiers

NCT06568653

IR.TUMS.IKHC.REC.1403.113

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

intervention

Experimental group

Treatment:

Procedure: exosome

control

Active Comparator group

Treatment:

Procedure: routine conventional fistulotomy