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Clinical Trials/IRCT20240128060828N1
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

Tehran University of Medical Sciences0 sites30 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

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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