[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557330":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":52,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Tehran University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mesenchymal Stem Cells Derived Exosomes","EXPERIMENTAL","10 patients in this arm will receive Mesenchymal Stem Cells Derived Exosomes at the end of their low anterior resection surgery",[13],"Biological: Mesenchymal Stem Cells Derived Exosomes",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","10 patients in this arm will receive placebo at the end of their low anterior resection surgery",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Mesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to patients at the end of their surgery",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"10 patients will receive intraperitoneal placebo at the end of their surgery",[15],[30],{"name":31,"affiliation":32,"role":33},"Seyed Mohsen Ahmadi Tafti, MD","Colorectal Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences,","STUDY_DIRECTOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+98(912)2109773","smahmadit@sina.tums.ac.ir",[40],{"facility":41,"status":25,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran","Tehran","1419733141","Iran","IR",{"type":47,"coordinates":48},"Point",[49,50],51.42151,35.69439,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ahmadi tafti","Assistant professor","100557330","phase-1-effects-of-exosome-adminstration-in-preventing-early-leakage-in-rectal-cancer-patients-undergoing-low-anterior-resection-100557330",false,"NCT06536712","Effects of Exosome Adminstration in Preventing Early Leakage in Rectal Cancer Patients Undergoing Low Anterior Resection","Investigating the Effect of Intraperitoneal Administration of Exosome in Preventing Early Anastomotic Leakage in Rectal Cancer Patients Who Undergo Low Anterior Resection","Inclusion Criteria:\n\n-Patients with Stage II-III rectal cancer who underwent neoadjuvant chemoradiation therapy and are candidates for low anterior resection surgery\n\nExclusion Criteria:\n\n* Patients who need emergency surgery (presenting with peritonitis or signs of obstruction)\n* Patients with apparent malnutrition or patients who have serum albumin levels of less than 3 g\u002Fdl\n* Patients who receive corticosteroids ( an equivalent dose of prednisolone 5 mg\u002Fday or more)\n* Patients with chronic pulmonary disease\n* Patients who need more than two units of blood transfusion perioperatively","ALL","18 Years","75 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","The goal of this clinical trial is to assess the safety and efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes in preventing early anastomosis leak in patients undergoing low anterior resection for rectal cancer. The main question it aims to answer are\n\nDo Mesenchymal Stem Cell-Derived Exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer?\n\nIf there is a comparison group: Researchers will compare Mesenchymal Stem Cells Derived Exosomes to placebo to see if it can prevent early anastomotic leakage.\n\nParticipants will receive intraperitoneal Mesenchymal Stem Cells Derived Exosomes at the end of their surgery.",[74],"Rectal Cancer","NOT_YET_RECRUITING","2024-08-02",{"date":78,"type":79},"2024-08-05","ACTUAL",{"date":81,"type":68},"2024-08",{"date":83,"type":68},"2024-12",{"name":5,"class":6},1]