[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559785":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":28,"collaborators":11,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":11,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":11,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Tehran University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention","EXPERIMENTAL",null,[13],"Procedure: exosome",{"label":15,"type":16,"description":11,"interventionNames":17},"control","ACTIVE_COMPARATOR",[18],"Procedure: routine conventional fistulotomy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","exosome","human placenta mesenchymal stem cell-derived exosome",[9],{"type":21,"name":26,"description":26,"armGroupLabels":27,"otherNames":11},"routine conventional fistulotomy",[15],{"type":29,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100559785","phase-2-human-placenta-mesenchymal-stem-cells-derived-exosomes-injection-for-treatment-of-complex-anal-fistula-100559785",false,"NCT06568653","Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula","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.","Inclusion Criteria:\n\n* participants with complex perianal fistula\n* provided written informed consent\n\nExclusion Criteria:\n\n* participants with any inflammatory bowel diseases\n* pregnant or lactating participants\n* participants with contraindications for surgery\n* participants with hepatitis\n* participants with uncontrolled diabetes\n* participants with alcohol or substance abuse","ALL","18 Years","70 Years",{"count":41,"type":42},40,"ESTIMATED","INTERVENTIONAL",[45],"PHASE2","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:\n\n* Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants?\n* 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.\n\nParticipants will:\n\n* Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone.\n* Visit the clinic the week after surgery and then every 4 weeks for checkups and tests",[48],"Fistula Perianal",[50],"fistula, perianal fistula, non-Crohn's disease, exosome, mesenchymal stem cell, human placenta stem cell","NOT_YET_RECRUITING","2024-08-22",{"date":54,"type":55},"2024-08-23","ACTUAL",{"date":57,"type":42},"2024-09-15",{"date":59,"type":42},"2025-02-15",{"name":5,"class":6}]