[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582691":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":11,"studyPopulation":11,"armGroups":46,"interventions":64,"overallOfficials":78,"centralContacts":85,"locations":91,"responsibleParty":107,"collaborators":11,"id":109,"slug":11,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":11,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":11,"studyType":121,"phases":122,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":133,"whyStopped":11,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"HELP Therapeutics Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"6-minute walk test",null,"baseline, 1, 3, 6, 12 months post-operation",{"measure":14,"description":15,"timeFrame":16},"Major Adverse Cardiovascular Events","The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).","From enrollment to the end of study at 12 months",{"measure":18,"description":11,"timeFrame":16},"Survival rate",[20,23,26,29,32,35],{"measure":21,"description":22,"timeFrame":12},"Left ventricular ejection fraction","Improvement of left ventricular ejection fraction assessed by ECHO",{"measure":24,"description":25,"timeFrame":12},"Cardiac magnetic resonance detection index","Myocardial infarction size and Myocardial fibrosis assessed by MRI",{"measure":27,"description":28,"timeFrame":12},"BNP","BNP levels are measured by venous blood samples",{"measure":30,"description":31,"timeFrame":12},"SF-36","life quality assessed by SF-36 (The Short-Form-36 Health Survey). The SF-36 scale is a tool used to assess health-related quality of life, including eight dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Each dimension has its unique scoring criteria, and the score range for each dimension is from 0 to 100 points. Higher scores indicate better health outcomes",{"measure":33,"description":34,"timeFrame":12},"KCCQ","Kansas City Cardiomyopathy Questionnaire, KCCQ is designed to assess the health status and quality of life of patients with heart failure. The score range is from 0 to 100 and higher scores reflect better health status and quality of life.",{"measure":36,"description":37,"timeFrame":16},"Removal rate of LVAD","Percentage of subjects who had their Left Ventricular Assist Device (LVAD) successfully removed after surgery",{"allocation":39,"interventionModel":40,"interventionModelDescription":11,"primaryPurpose":41,"observationalModel":11,"timePerspective":11,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":11,"whoMasked":44},"SINGLE",[45],"OUTCOMES_ASSESSOR",[47,53,59],{"label":48,"type":49,"description":50,"interventionNames":51},"Control group","SHAM_COMPARATOR","CABG combined with saline or LVAD combined with saline",[52],"Other: CABG\u002FLVAD+Saline",{"label":54,"type":55,"description":56,"interventionNames":57},"Low Dose Group","EXPERIMENTAL","CABG combined with 0.5×10\\^8 iPSC-CMs",[58],"Biological: low dose CABG+iPSC-CMs",{"label":60,"type":55,"description":61,"interventionNames":62},"High dose group","CABG combined with 1.5×10\\^8 iPSC-CMs or LVAD combined with 1.5×10\\^8 iPSC-CMs",[63],"Biological: High dose CABG\u002FLVAD+iPSC-CMs",[65,70,74],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":11},"BIOLOGICAL","low dose CABG+iPSC-CMs","CABG+0.5×10\\^8 iPSC-CMs",[54],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":11},"High dose CABG\u002FLVAD+iPSC-CMs","CABG+1.5×10\\^8 iPSC-CMs or LVAD+1.5×10\\^8 iPSC-CMs",[60],{"type":75,"name":76,"description":76,"armGroupLabels":77,"otherNames":11},"OTHER","CABG\u002FLVAD+Saline",[48],[79,83],{"name":80,"affiliation":81,"role":82},"Yongfeng Shao, MD, PhD","Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)","PRINCIPAL_INVESTIGATOR",{"name":84,"affiliation":81,"role":82},"Liansheng Wang, MD, PhD",[86],{"name":87,"role":88,"phone":89,"phoneExt":11,"email":90},"Jiaxian Wang, MD, PhD","CONTACT","+86-18565616060","wangjx@helpsci.com.cn",[92],{"facility":93,"status":11,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"HelpThera","Nanjing","Jiangsu","210000","China","CN",{"type":100,"coordinates":101},"Point",[102,103],118.77778,32.06167,{"lat":103,"lon":102},[106],{"name":87,"role":88,"phone":89,"phoneExt":11,"email":90},{"type":108,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100582691",false,"NCT06866600","IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure","Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure","Inclusion Criteria:\n\n* Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.\n* Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.\n* Diagnosed with end-stage heart failure.\n* Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.\n* Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.\n* Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%.\n* Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory.\n* Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery.\n* For patients enrolled in the LVAD implantation group, the following additional criteria must be met:\n\n  1. Definitive indication for LVAD implantation due to end-stage heart failure.\n  2. Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.\n  3. Absence of significant contraindications for LVAD surgery.\n\nExclusion Criteria:\n\n* History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).\n* Severe valvular heart disease.\n* Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.\n* Non-ischemic cardiomyopathy or acute viral myocarditis.\n* Acute cerebrovascular event within 1 month prior to screening.\n* History of malignancy within 5 years prior to screening.\n* Autoimmune disease or chronic use of immunosuppressive agents.\n* History of organ transplantation.\n* Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure\u002Fresection).\n* Malignant ventricular arrhythmia.\n* Contraindications for CABG surgery.\n* Positive serology for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody.\n* Inability to undergo cardiac MRI or PET\u002FCT imaging.\n* Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.\n* Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate\u002Fmethylprednisolone, other corticosteroids, or basiliximab.\n* Participation in another clinical trial within 3 months prior to screening.\n* Pregnancy, lactation, or positive pregnancy test in female patients.\n* Any other condition deemed by the investigator to render the patient unsuitable for trial participation.","ALL","35 Years","75 Years",{"count":119,"type":120},40,"ESTIMATED","INTERVENTIONAL",[123,124],"PHASE1","PHASE2","This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.",[127,128],"Heart Failure","Heart Failure At NYHA Stage III or IV",[130,131,132],"LVAD","CABG","iPSC-CMs","NOT_YET_RECRUITING","2025-03-11",{"date":136,"type":137},"2025-03-14","ACTUAL",{"date":139,"type":120},"2025-03",{"date":141,"type":120},"2027-12",{"name":5,"class":6},1]