[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HELP Therapeutics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,81,103],{"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":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100643103","phase-1-hicm-188-cell-therapy-in-adults-with-advanced-heart-failure-undergoing-heart-bypass-surgery-100643103",false,"NCT07646210","HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery","A Phase I\u002FIIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure","Inclusion Criteria:\n\n* Able to sign informed consent and comply with the study protocol\n* 18 to 75 years old at the time of signing informed consent\n* Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)\n* Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF\u002FAHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa\n* Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI\n* Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI\n* Other criteria apply. Please contact the investigator for more information.\n\nExclusion Criteria:\n\n* Viral myocarditis\n* Amyloidosis\n* Pericardial disorders or pericarditis\n* Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area\n* Primary significant organic valvular heart disease, with specified dimensions\n* Untreated congenital heart disease\n* Complete atrioventricular (AV) conduction block\n* History of left ventricular assist device surgery\n* Other criteria apply. Please contact the investigator for more information.","ALL","18 Years","75 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery.\n\nParticipants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.",[28,29],"Advanced Heart Failure","Ischemic Heart Failure",[31,32,33,34,35,36,37,38,39,40],"HiCM-188","iPSC-derived cardiomyocytes","Allogeneic cell therapy","Advanced heart failure","Ischemic heart failure","Intramyocardial injection","Coronary artery bypass grafting","CABG","Dose escalation","NYHA Class III-IVa","NOT_YET_RECRUITING","2026-06-25",{"date":44,"type":45},"2026-06-29","ACTUAL",{"date":47,"type":21},"2026-09",{"date":49,"type":21},"2028-05",{"name":51,"class":52},"HELP Therapeutics Co., Ltd.","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":53},"100631107","phase-3-a-pivotal-clinical-trial-of-human-induced-pluripotent-stem-cell-derived-cardiomyocytes-injection-hicm-188-for-the-treatment-of-advanced-heart-failurenyha-iii-iv-100631107","NCT07496372","A Pivotal Clinical Trial of Human Induced Pluripotent Stem Cell-derived Cardiomyocytes Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)","A Pivotal Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)","REVIVE-HEART","Inclusion Criteria:\n\n1. Aged 18 to 75 years, regardless of gender;\n2. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);\n3. LVEF ≤ 35% as measured by cardiac MRI;\n4. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;\n5. Voluntary participation and signing of the informed consent form.\n\nExclusion Criteria:\n\nPatients considered for this trial must not meet any of the following criteria:\n\n1. Acute viral myocarditis;\n2. Acute phase of myocardial infarction (≤ 3 months);\n3. Cardiac amyloidosis;\n4. Pericarditis;\n5. Expected to undergo heart transplantation;\n6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;\n7. Suffering from autoimmune diseases;\n8. Estimated glomerular filtration rate (eGFR) \\\u003C 35 ml\u002Fmin\u002F1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 100 U\u002FL;\n9. Presence of any untreated precancerous lesions or those requiring active monitoring;\n10. Occurrence of malignant tumors within 5 years prior to screening;\n11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision\u002Fligation);\n12. Having contraindications to the use of immunosuppressants;\n13. Having contraindications to MRI;\n14. Having contraindications to CABG surgery;\n15. Females who are pregnant, lactating, or have a positive blood pregnancy test;\n16. Plans to conceive within one year;\n17. Having systemic diseases that are not effectively controlled;\n18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.",{"count":63,"type":21},80,[65],"PHASE3","The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)",[68],"Heart Failure",[34,70,31,60,71],"HiCM188","cardiomyocyte","RECRUITING","2026-05-07",{"date":75,"type":45},"2026-05-12",{"date":77,"type":21},"2026-04-30",{"date":79,"type":21},"2027-08-31",{"name":51,"class":52},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":53},"100629209","phase-1-hipsc-cms-loaded-chitosan-patch-to-treat-severe-chronic-ischemic-heart-disease-100629209","NCT07471698","hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Human Induce Pluripotent Stem Cell-derived Cardiomyocytes(HiCM-188) -Loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease","Inclusion Criteria:\n\n1. Age between 18 and 80 years (inclusive).\n2. Willingness and ability to give written informed consent.\n3. Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria.\n4. NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure.\n5. Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:\n\n   5.1 Class I Indications :\n   1. Left ventricular dysfunction with significant left main coronary artery disease;\n   2. Left ventricular dysfunction with \"left main equivalent\" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx);\n   3. Left ventricular dysfunction with two- or three-vessel disease including proximal LAD stenosis.\n\n   5.2 Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria.\n6. Left ventricular ejection fraction (LVEF) ≤40% as measured by echocardiography or cardiac MRI within 6 months prior to enrollment (excluding measurements obtained within 1 month post-myocardial infarction).\n7. Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are ineligible for study participation:\n\n1. History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.\n2. Severe valvular heart disease or prior prosthetic valve replacement.\n3. Prior percutaneous coronary intervention (PCI) with stent implantation.\n4. Chronic atrial fibrillation.\n5. History of sustained ventricular tachycardia or aborted sudden cardiac death.\n6. Baseline estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m².\n7. Hematocrit \\\u003C25%.\n8. Severe contrast media allergy (anaphylactic or life-threatening reaction history).\n9. Coagulation disorder (INR \\>1.5 without therapeutic anticoagulation, platelets \\\u003C50×10⁹\u002FL, or clinically significant bleeding diathesis).\n10. Known hypersensitivity to penicillin or streptomycin.\n11. Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication).\n12. History of solid organ or bone marrow transplantation.\n13. Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ).\n14. Life expectancy \\\u003C1 year due to non-cardiac conditions.\n15. Long-term systemic immunosuppressive therapy (e.g., corticosteroids, TNF-α inhibitors).\n16. Contraindications to immunosuppressive therapy (e.g., active infection, uncontrolled diabetes, peptic ulcer disease).\n17. Active infectious diseases: HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum, TP).\n18. Currently participating in another interventional clinical trial.\n19. Pregnant or lactating women.","80 Years",{"count":90,"type":21},16,[24,25],"This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups:\n\n1. CABG + HiCM-188-loaded chitosan patch group (patch size: 2×4 cm; containing 5 million cells per patch)\n2. CABG + blank chitosan patch group (identical in appearance but without HiCM-188 cells).\n\nDuring CABG surgery, investigators will apply two HiCM-188-loaded chitosan patches onto the epicardial surface over regions of hypokinetic myocardium. The total transplanted cell dose per patient in the treatment group is 1 × 10⁷ . In the control group, eight patients will undergo identical surgical procedures with application of chitosan patches without HiCM-188 cells.",[29,94],"CABG-patients","2026-03-10",{"date":97,"type":45},"2026-03-13",{"date":99,"type":21},"2026-10-20",{"date":101,"type":21},"2028-10-20",{"name":51,"class":52},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":18,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":53},"100582691","phase-1-ipsc-cms-combined-with-lvad-or-cabg-for-the-treatment-of-heart-failure-100582691","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.","35 Years",{"count":112,"type":21},40,[24,25],"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.",[68,116],"Heart Failure At NYHA Stage III or IV",[118,38,119],"LVAD","iPSC-CMs","2025-03-11",{"date":122,"type":45},"2025-03-14",{"date":124,"type":21},"2025-03",{"date":126,"type":21},"2027-12",{"name":51,"class":52},""]