[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477606":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":22,"locations":23,"responsibleParty":36,"collaborators":22,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":22,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":22,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":22,"overallStatus":57,"whyStopped":22,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Tehran University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"exosome therapy","EXPERIMENTAL","placenta-MSCs derived exosomes Exosomes are extracellular vesicles that are 30 to 150 nm in diameter. These vesicles are secreted from various cells. Mesenchymal stem cells exhibit immunomodulatory and anti-inflammatory properties by using paracrine effects. Exosomes, as a vehicle for signaling, are responsible for a significant part of cell-to-cell signaling. The preclinical animal studies manifested high safety and efficacy for MSC-derived exosome treatment on various fistulas and inflammatory bowel disease. In this study, we aimed to evaluate the safety and effectiveness of PlacentaMSCs derived exosomes in the treatment of patients with complex preanal fistula (Crohn's) in phases I and II of the clinical trial",[13],"Other: placenal MSC derived exosomes",{"label":15,"type":10,"description":15,"interventionNames":16},"placebo",[13],[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"placenal MSC derived exosomes","placenta-MSCs derived exosomes Exosomes are extracellular vesicles that are 30 to 150 nm in diameter. these vesicles are secreted from various cells. Mesenchymal stem cells exhibit immunomodulatory and anti- inflammatory properties by the use of paracrine effects. Exosomes as a vehicle for signaling, are responsible for a major part of cell to cell signaling. The preclinical animal studies manifested high safety and efficacy for MSC derived exosome treatment on various fistulas and inflammatory bowel disease. In this study we aimed to evaluate the safety and efficacy of PlacentaMSCs derived exosomes in treatment of patients with complex preanal fistula (non-crohn's) in phase I and II of clinical trial",[9,15],null,[24],{"facility":25,"status":22,"city":26,"state":22,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":22},"Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran","Tehran","1978775553","Iran","IR",{"type":31,"coordinates":32},"Point",[33,34],51.42151,35.69439,{"lat":34,"lon":33},{"type":37,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100477606","phase-1-safety-of-injection-of-placental-mesenchymal-stem-cell-derived-exosomes-for-treatment-of-resistant-perianal-fistula-in-crohns-patients-100477606",false,"NCT05499156","Safety of Injection of Placental Mesenchymal Stem Cell Derived Exosomes for Treatment of Resistant Perianal Fistula in Crohn's Patients","Inclusion Criteria:\n\n1. Age between 18-70 years old\n2. Occurrence of complex perianal fistula\n3. Informed consent\n\nExclusion Criteria:\n\n1. Active inflammatory bowel disease\n2. Synchronous perianal abscess\n3. Alcohol,narcotic and stimulant consumption\n4. Having active Hepatitis B,C,HIV or TB\n5. Peregnancy and lactation\n6. Uncontrolled diabetes mellitus\n7. Evidence of surgical contraindication\n8. Psychological disorders and noncooperative patient","ALL","18 Years","70 Years",{"count":48,"type":49},80,"ACTUAL","INTERVENTIONAL",[52,53],"PHASE1","PHASE2","Study aim:\n\nSafety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of perianal fistula in patients with Crohn's disease 2. Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula in patients with Crohn's disease 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\n\nParticipants\u002FInclusion and exclusion criteria:\n\ninclusion criteria: 1. Age between 18-70 years old 2.Occurrence in patients with Crohn's disease 3. Informed consent Exclusion Criteria: 1. Active inflammatory bowel disease 2. Synchronous perianal abscess 3. Alcohol, narcotics and stimulant consumption 4. Having active Hepatitis B, C, HIV, or TB 5. Pregnancy and lactation 6.Uncontrolled diabetes mellitus 7. Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient\n\nIntervention groups:\n\nHuman 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 were evaluated.\n\nDesign:\n\nthis study includes two separate groups of cases and controls, each consisting of 40 participants randomly allocated for phase 2 of a clinical trial.\n\nSettings and conduct:\n\nPatients 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 three consecutive weeks. Patients will be reexamined and fill out the questionnaire, and MRI will be done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examined for complications.\n\nMain outcome variables:\n\nDischarge 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",[56],"Perianal Fistula in Patients With Crohn's Disease","UNKNOWN","2022-08-11",{"date":60,"type":49},"2022-08-12",{"date":62,"type":49},"2022-01-20",{"date":64,"type":65},"2022-09","ESTIMATED",{"name":5,"class":6},1]