[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100269053":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":22,"locations":27,"responsibleParty":63,"collaborators":11,"id":65,"slug":11,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Metcela Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous cardiac stem cells (JRM-001)","EXPERIMENTAL",null,[13],"Genetic: Autologous cardiac stem cells (JRM-001)",{"label":15,"type":16,"description":11,"interventionNames":11},"Usual care","NO_INTERVENTION",[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":11},"GENETIC","3x 10\\^5 cells\u002Fkg, single treatment",[9],[23],{"name":24,"role":25,"phone":11,"phoneExt":11,"email":26},"Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)","CONTACT","info@j-rm.com",[28,39,47,55],{"facility":29,"status":30,"city":31,"state":11,"zip":11,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":11},"Kanagawa Children's Medical Center","RECRUITING","Kanagawa","Japan",{"type":34,"coordinates":35},"Point",[36,37],139.91667,37.58333,{"lat":37,"lon":36},{"facility":40,"status":30,"city":41,"state":11,"zip":11,"country":32,"cosmosGeoPoint":42,"geoPoint":46,"contacts":11},"Okayama University Hospital","Okayama",{"type":34,"coordinates":43},[44,45],133.93333,34.65,{"lat":45,"lon":44},{"facility":48,"status":30,"city":49,"state":11,"zip":11,"country":32,"cosmosGeoPoint":50,"geoPoint":54,"contacts":11},"Saitama Prefectural Children's Medical Center","Saitama",{"type":34,"coordinates":51},[52,53],139.65657,35.90807,{"lat":53,"lon":52},{"facility":56,"status":30,"city":57,"state":11,"zip":11,"country":32,"cosmosGeoPoint":58,"geoPoint":62,"contacts":11},"Shizuoka Children's Hospital","Shizuoka",{"type":34,"coordinates":59},[60,61],138.38333,34.98333,{"lat":61,"lon":60},{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100269053",false,"NCT02781922","Cardiac Stem\u002FProgenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)","Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study","APOLLON","Inclusion Criteria:\n\n* Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery\n* EF(%) by echocardiography ≤ 55%\n* Able to obtain written informed consent of participation in the study by a parent of the patient\n\nExclusion Criteria:\n\n* Known medical history of cardiogenic shock\n* Lethal, uncontrollable arrhythmia\n* Complication of coronary artery disease\n* Eisenmenger syndrome\n* Complication of brain dysfunction due to circulatory failure\n* Malignant neoplasm\n* Complication of severe neurologic disorder\n* Severe pulmonary embolism or pulmonary hypertension\n* Severe renal failure\n* Multiple organ failure\n* Active infection (including endocarditis)\n* Sepsis\n* Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)\n* Known history of hypersensitivity to anti-infective drugs\n* Inability to complete the protocol treatment and baseline to follow-up examinations","ALL","0 Years","6 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle",[83,84],"Hypoplastic Left Heart Syndrome","Single Ventricle",[86,87,88,89],"cardiac stem\u002Fprogenitor cells","autologous cell therapy","functional single ventricle","congenital heart disease","2025-09-24",{"date":92,"type":93},"2025-09-30","ACTUAL",{"date":95,"type":11},"2016-06",{"date":97,"type":77},"2028-12",{"name":5,"class":6},4]