[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Metcela Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100269053","phase-3-cardiac-stemprogenitor-cell-infusion-in-univentricular-physiology-apollon-trial-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":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"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",[28,29],"Hypoplastic Left Heart Syndrome","Single Ventricle",[31,32,33,34],"cardiac stem\u002Fprogenitor cells","autologous cell therapy","functional single ventricle","congenital heart disease","RECRUITING","2025-09-24",{"date":38,"type":39},"2025-09-30","ACTUAL",{"date":41,"type":4},"2016-06",{"date":43,"type":22},"2028-12",{"name":45,"class":46},"Metcela Inc.","INDUSTRY",4,""]