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NCT Number: NCT06568653

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

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

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Key information

Conditions

Fistula Perianal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exosome

Procedure

human placenta mesenchymal stem cell-derived exosome

routine conventional fistulotomy

Procedure

routine conventional fistulotomy

Primary outcomes

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

    Time frame: 3 months

    clinical improvement

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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