Investigating the effect of stromal/mesenchymal stem cell-derived exosomes in patients with perianal fistula

Phase 1

Recruiting

• Conditions: Perianal Fistula.; Anal fistula; K60.3

• Registration Number: IRCT20240128060828N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

sign the informed consent
Patients with complex perianal fistula aged 18-75
Acceptable general health of patients based on physical tests and medical history (absence of diseases or disorders that may interfere with the treatment method evaluated in this study)

Exclusion Criteria

Patients with underlying diseases that affect the pathophysiology of perianal fistula (including IBD, rectovaginal fistula or acute sepsis, uncontrolled diabetes, and active or latent HIV, HBV, or HCV infection)
Patients who need perianal surgery for reasons other than fistula
Major surgeries within 28 days before admission
Use of immune system modulators for reasons other than fistula in patients

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of any regional undesirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion.;Evaluation of any systemic undsirable events. Timepoint: Within 48 to 72 hours. Method of measurement: In the form of a phone call and based on the patient's opinion.;Degree of healing recorded by surgeon examination. Timepoint: Examination of the patient's condition during 6 months of follow-up. Method of measurement: by laboratory tests and especially during examination under anesthesia (EUA).;Degree of self satisfaction and quality of life recorded by patients. Timepoint: After the termination of the follow-up of the patient's condition. Method of measurement: By using special questionnaires for the health context of 36-Item Short Form Survey (SF-36).