Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
Phase 2
Not yet recruiting
- Conditions
- Fistula Perianal
- Registration Number
- NCT06568653
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Inclusion Criteria:<br><br> - participants with complex perianal fistula<br><br> - provided written informed consent<br><br>Exclusion Criteria:<br><br> - participants with any inflammatory bowel diseases<br><br> - pregnant or lactating participants<br><br> - participants with contraindications for surgery<br><br> - participants with hepatitis<br><br> - participants with uncontrolled diabetes<br><br> - participants with alcohol or substance abuse
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of fistula openings (orifices) will be assessed before and after our intervention.
- Secondary Outcome Measures
Name Time Method QoL questionnaire
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie exosome-mediated tissue regeneration in complex anal fistula treatment?
How does placenta MSC-derived exosome therapy compare to anti-TNF agents in complex anal fistula healing rates?
Which biomarkers correlate with response to exosome therapy in perianal fistula patients with Crohn's disease?
What adverse events are associated with placenta exosome injections in Phase II trials for anorectal conditions?
Are there synergistic effects combining placenta exosomes with PRP or other stem cell-derived therapies for fistulas?