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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTehran University of Medical Sciences

About this 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

Eligibility criteria

Qualifiers

participants with complex perianal fistula

provided written informed consent

Disqualifiers

participants with any inflammatory bowel diseases

pregnant or lactating participants

participants with contraindications for surgery

participants with hepatitis

Trial design

Treatments tested in this trial

  • exosome
  • routine conventional fistulotomy

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations