[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631107":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":31,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"HELP Therapeutics Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","Coronary artery bypass grafting surgery",[13],"Procedure: CABG surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental group","EXPERIMENTAL","Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery",[19,13],"Biological: HiCM-188 therapy",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","HiCM-188 therapy",[15],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","CABG surgery","Conventional coronary artery bypass grafting (CABG) surgery",[9,15],[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"TEDA International Cardiovascular Hospital","RECRUITING","Tianjin","Tianjin Municipality","300457","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.17667,39.14222,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":25,"email":51},"Xiaocheng Liu","CONTACT","+86-022-65208030","liuxc@tedaich.com",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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",false,"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.","ALL","18 Years","75 Years",{"count":66,"type":67},80,"ESTIMATED","INTERVENTIONAL",[70],"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)",[73],"Heart Failure",[75,76,77,60,78],"Advanced heart failure","HiCM188","HiCM-188","cardiomyocyte","2026-05-07",{"date":81,"type":82},"2026-05-12","ACTUAL",{"date":84,"type":67},"2026-04-30",{"date":86,"type":67},"2027-08-31",{"name":5,"class":6},1]