Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
- Conditions
- Fistula Perianal
- Registration Number
- NCT06568653
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- participants with complex perianal fistula
- provided written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The number of fistula openings (orifices) will be assessed before and after our intervention. 3 months clinical improvement
- Secondary Outcome Measures
Name Time Method QoL questionnaire 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
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.