[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619636":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":26,"collaborators":20,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":20,"studyType":42,"phases":43,"briefSummary":46,"conditions":47,"keywords":52,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":20},{"fullName":5,"class":6},"Heartseed Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","HS-005 administration",[13],"Combination Product: HS-005",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","HS-005","Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems",[9],null,[22],{"name":5,"role":23,"phone":24,"phoneExt":20,"email":25},"CONTACT","+8163801068","contact@heartseed.jp",{"type":27,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100619636","phase-1-endocardial-delivery-for-myocardial-regeneration-using-allogeneic-ipsc-derived-cardiomyocyte-spheroids-for-hf-with-systolic-dysfunction-emerald-study-100619636",false,"NCT07347197","Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)","A Phase I\u002FII Study of Endocardial Delivery for Myocardial Regeneration Using Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids for Heart Failure Reduced Ejection Fraction","EMERALD","Inclusion Criteria:\n\n* Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on screening echocardiographic assessment\n* New York Heart Association (NYHA) cardiac function classification of grade II or III at screening\n* Other Criteria apply, please contact the investigator\n\nExclusion Criteria:\n\n* Patients with cardiac devices such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resuscitation-enabled implantable cardioverter defibrillators (CRT-Ds)\n* Patients with heart failure due to the primary disease hypertrophic cardiomyopathy (including the dilated phase), restrictive cardiomyopathy, amyloidosis, takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis\n* Other Criteria apply, please contact the investigator","ALL","20 Years","80 Years",{"count":40,"type":41},14,"ESTIMATED","INTERVENTIONAL",[44,45],"PHASE1","PHASE2","The purpose of this clinical study is to evaluate the safety and efficacy of endocardial delivery of HS-001 CS into severe heart failure patients with reduced ejection fraction for 26 weeks after transplantation.",[48,49,50,51],"Heart Failure","Ischemic Heart Failure","Ischemic Heart Disease","Dilated Cardiomyopathy (DCM)",[48,53,50,51,54,55],"Ischemic heart failure","iPSC","cell therapy","NOT_YET_RECRUITING","2026-01-08",{"date":59,"type":60},"2026-01-16","ACTUAL",{"date":62,"type":41},"2026-01-01",{"date":64,"type":41},"2030-01-31",{"name":5,"class":6}]