NCT06568653
Not yet recruiting
Phase 2
The Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula in Colorectal Surgery Department of Imam Khomeini Hospital Complex: A Non-randomized Clinical Trial.
ConditionsFistula Perianal
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Fistula Perianal
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 40
- Primary Endpoint
- The number of fistula openings (orifices) will be assessed before and after our intervention.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •participants with complex perianal fistula
- •provided written informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The number of fistula openings (orifices) will be assessed before and after our intervention.
Time Frame: 3 months
clinical improvement
Secondary Outcomes
- QoL questionnaire(3 months)
Similar Trials
Recruiting
Phase 1
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal FistulaFistula PerianalNCT05402748Tehran University of Medical Sciences80
Unknown
Phase 1
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS)Ankylosing SpondylitisNCT01420432Shandong University10
Unknown
Phase 2
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic AnemiaAplastic AnemiaNCT01182662Shandong University30
Unknown
Phase 2
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic SyndromesMyelodysplastic SyndromesNCT01129739Shandong University30
Unknown
Phase 1
Safety of Injection of Placental Mesenchymal Stem Cell Derived Exosomes for Treatment of Resistant Perianal Fistula in Crohn's PatientsPerianal Fistula in Patients With Crohn's DiseaseNCT05499156Tehran University of Medical Sciences80