[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582691":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":47,"locations":53,"responsibleParty":69,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":31,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":31,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":96,"whyStopped":31,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"HELP Therapeutics Co., Ltd.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","SHAM_COMPARATOR","CABG combined with saline or LVAD combined with saline",[13],"Other: CABG\u002FLVAD+Saline",{"label":15,"type":16,"description":17,"interventionNames":18},"Low Dose Group","EXPERIMENTAL","CABG combined with 0.5×10\\^8 iPSC-CMs",[19],"Biological: low dose CABG+iPSC-CMs",{"label":21,"type":16,"description":22,"interventionNames":23},"High dose group","CABG combined with 1.5×10\\^8 iPSC-CMs or LVAD combined with 1.5×10\\^8 iPSC-CMs",[24],"Biological: High dose CABG\u002FLVAD+iPSC-CMs",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","low dose CABG+iPSC-CMs","CABG+0.5×10\\^8 iPSC-CMs",[15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"High dose CABG\u002FLVAD+iPSC-CMs","CABG+1.5×10\\^8 iPSC-CMs or LVAD+1.5×10\\^8 iPSC-CMs",[21],{"type":37,"name":38,"description":38,"armGroupLabels":39,"otherNames":31},"OTHER","CABG\u002FLVAD+Saline",[9],[41,45],{"name":42,"affiliation":43,"role":44},"Yongfeng Shao, MD, PhD","Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":43,"role":44},"Liansheng Wang, MD, PhD",[48],{"name":49,"role":50,"phone":51,"phoneExt":31,"email":52},"Jiaxian Wang, MD, PhD","CONTACT","+86-18565616060","wangjx@helpsci.com.cn",[54],{"facility":55,"status":31,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"HelpThera","Nanjing","Jiangsu","210000","China","CN",{"type":62,"coordinates":63},"Point",[64,65],118.77778,32.06167,{"lat":65,"lon":64},[68],{"name":49,"role":50,"phone":51,"phoneExt":31,"email":52},{"type":70,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100582691","phase-1-ipsc-cms-combined-with-lvad-or-cabg-for-the-treatment-of-heart-failure-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":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86,87],"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.",[90,91],"Heart Failure","Heart Failure At NYHA Stage III or IV",[93,94,95],"LVAD","CABG","iPSC-CMs","NOT_YET_RECRUITING","2025-03-11",{"date":99,"type":100},"2025-03-14","ACTUAL",{"date":102,"type":83},"2025-03",{"date":104,"type":83},"2027-12",{"name":5,"class":6},1]