[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643103":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":24,"id":50,"slug":24,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":24,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":24,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":81,"whyStopped":24,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"HELP Therapeutics Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HiCM-188 Low Dose","EXPERIMENTAL","Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10\\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.",[13],"Drug: HiCM-188 Cells",{"label":15,"type":10,"description":16,"interventionNames":17},"HiCM-188 High Dose","Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10\\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","HiCM-188 Cells","HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Alex Zhang","CONTACT","+1 650 504 5586","Alex.zhang@helptx.com.cn",[32],{"facility":33,"status":24,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"The Texas Heart Institute at Baylor College of Medicine","Houston","Texas","77030","United States",{"type":39,"coordinates":40},"Point",[41,42],-95.36327,29.76328,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":24,"phoneExt":24,"email":24},"Emerson Perin","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":60,"type":61},12,"ESTIMATED","INTERVENTIONAL",[64,65],"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.",[68,69],"Advanced Heart Failure","Ischemic Heart Failure",[71,72,73,74,75,76,77,78,79,80],"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":84,"type":85},"2026-06-29","ACTUAL",{"date":87,"type":61},"2026-09",{"date":89,"type":61},"2028-05",{"name":5,"class":6},1]