protocolSection identificationModule nctId: NCT06340048, orgStudyIdInfo id: XC Liu, briefTitle: Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-05, primaryCompletionDateStruct date: 2024-09-05, completionDateStruct date: 2025-03-05, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Help Therapeutics, class: INDUSTRY, collaborators name: TEDA International Cardiovascular Hospital, descriptionModule briefSummary: The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: HiCM-188 therapy, outcomesModule primaryOutcomes measure: The incidence of major Serious Adverse Events (SAE), secondaryOutcomes measure: Grade 4 or above arrhythmias, secondaryOutcomes measure: The incidence of tumor, secondaryOutcomes measure: Left ventricular geometry as assessed by cardiac magnetic resonance imaging (MRI), secondaryOutcomes measure: Size of myocardial infarction as assessed by MRI, secondaryOutcomes measure: Ventricular wall motion as assessed by MRI, secondaryOutcomes measure: Left ventricular ejection fraction as assessed by MRI, secondaryOutcomes measure: Cardiac Volumes as assessed by MRI, secondaryOutcomes measure: Cardiac output (CO) as assessed by MRI, secondaryOutcomes measure: 10.End-diastolic myocardial mass as assessed by MRI, secondaryOutcomes measure: Left ventricular ejection fraction (LVEF) as assessed by Echocardiography, secondaryOutcomes measure: Fractional shortening (FS) as assessed by Echocardiography, secondaryOutcomes measure: Left ventricular dimensions as assessed by Echocardiography, secondaryOutcomes measure: Cardiac Volumes as assessed by Echocardiography, secondaryOutcomes measure: Mitral valve inflow spectrum(E/A) as assessed by Echocardiography, secondaryOutcomes measure: Longitudinal strain as assessed by Echocardiography, secondaryOutcomes measure: Myocardial viability as assessed by SPECT, secondaryOutcomes measure: Myocardial blood flow as assessed by SPECT, secondaryOutcomes measure: NT-proBNP Levels, secondaryOutcomes measure: 6-minute walking distance, secondaryOutcomes measure: New York Heart Association (NYHA) functional classification, secondaryOutcomes measure: Changes of Quality of Life (QoL) as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ), secondaryOutcomes measure: Changes of Quality of Life(QOL) as assessed by 36-Item Short Form Survey (SF-36), eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TEDA International Cardiovascular Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300457, country: China, contacts name: Xiaocheng Liu, role: CONTACT, phone: +86-022-65208030, contacts name: Xiaocheng Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False