[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-at-nyha-stage-iii-or-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-at-nyha-stage-iii-or-iv":46},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29],"Heart Failure","Heart Failure At NYHA Stage III or IV",[31,32,33],"LVAD","CABG","iPSC-CMs","NOT_YET_RECRUITING","2025-03-11",{"date":37,"type":38},"2025-03-14","ACTUAL",{"date":40,"type":21},"2025-03",{"date":42,"type":21},"2027-12",{"name":44,"class":45},"HELP Therapeutics Co., Ltd.","INDUSTRY","Heart Failure at NYHA Stage III or IV"]