[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643103":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":24,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"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,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"The Texas Heart Institute at Baylor College of Medicine","Houston","Texas","77030","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-95.36327,29.76328,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":24,"phoneExt":24,"email":24},"Emerson Perin","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":62,"type":63},12,"ESTIMATED","INTERVENTIONAL",[66,67],"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.",[70,71],"Advanced Heart Failure","Ischemic Heart Failure",[73,74,75,76,77,78,79,80,81,82],"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":86,"type":87},"2026-06-29","ACTUAL",{"date":89,"type":63},"2026-09",{"date":91,"type":63},"2028-05",{"name":5,"class":6},1]