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