Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
- Conditions
- Fistula Perianal
- Interventions
- Other: placenta-MSCs derived exosomes
- Registration Number
- NCT05402748
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Study aim:
Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula 3.Fistula changes in MRI studies, 12 weeks after treatment 4.Evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment
Participants/Inclusion and exclusion criteria:
inclusion Criteria : 1.Age between 18-70 years old 2.Occurrence of complex perianal fistula 3.Informed consent Exclusion Criteria: 1.Active inflammatory bowel disease 2.Synchronous perianal abscess 3.Alcohol,narcotic and stimulant consumption 4.Having active Hepatitis B,C,HIV or TB 5.Peregnancy and lactation 6.Uncontrolled diabetes mellitus 7.Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient
Intervention groups:
Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianal Fistula in 3 weekly episodes and it's safety and efficacy was evaluated.
Design:
this study includes two separate groups of cases and controls each consisting of 40 participants randomly allocated for the phase 2 of clinical trial.
Settings and conduct:
Patients with complex perianal fistula referred to Imam Khomeini hospital, will be included in the study if they contain inclusion criteria. The fistula was evaluated by clinical examination and MRI and patients fill the quality of life questionnaire. Exosome injections are performed weekly for consecutive three weeks. Patients will reexamined and fill the questionnaire and MRI will done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examine for complications.
Main outcome variables:
Discharge amount; External orifice re-epithelialization ; Inflammation, discharge and abscess larger than 2 cm in MR imaging; Quality of life questionnaire score, Inflammatory markers such as CRP, IL-6, TNF-a, calprotectin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Age between 18-70 years old
- Occurrence of complex perianal fistula
- Informed consent
- Active inflammatory bowel disease
- Synchronous perianal abscess
- Alcohol,narcotic and stimulant consumption
- Having active Hepatitis B,C,HIV or TB
- Peregnancy and lactation
- Uncontrolled diabetes mellitus
- Evidence of surgical contraindication
- Psychological disorders and noncooperative patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exosome cases placenta-MSCs derived exosomes The patients whose fistula is treated by exosome (40 patients). Controls placenta-MSCs derived exosomes The patients whose fistula is treated with conventional treatment plan (40 patients).
- Primary Outcome Measures
Name Time Method clinical Efficacy of injected exosomes 3 months assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas
inflammatory markers 3 months assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.
Safety of injected exosomes 3 months assessing the adverse outcomes after injection such as acute allergic reactions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
🇮🇷Tehran, Iran, Islamic Republic of