IRCT20240128060828N1
Recruiting
Phase 1
Evaluation of the safety and efficacy of the injection of placenta-derived mesenchymal stromal/stem cell exosomes with and without priming with TNF-a in patients with complex perianal fistula without a history of CHRONS disease: A double-blinded randomized controlled trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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