Chronic Heart Failure Clinical Trial
Official title:
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | July 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility | Inclusion Criteria: - Aged 35-75 (including 35 and 75). - Signed the Informed Consent Form (ICF). - Have chronic left ventricular dysfunction. - Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure. - Have indications for Coronary Artery Bypass Grafting. - LVEF < 40% as determined by echocardiogram (data collected up to 6 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid). - Weakening or absence of segmental regional wall motion as determined by standard imaging Exclusion Criteria: - PRA = 20% or DSA-positive - Patient received ICD transplantation, CRT or similar treatment. - Patients with valvular heart disease or received heart valvular disease - Patients received treatment of percutaneous transluminal coronary intervention (PCI) - Patients with atrial fibrillation - Patients previously suffered sustained ventricular tachycardia or sudden cardiac death. - Baseline glomerular filtration rate <30ml/min/1.73m2. - Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN. - Hematological abnormality: A hematocrit <25% as determined by HCT, white blood cell<2500/ul or platelet values <100000/ul without another explanation. - Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy. - Coagulopathy (INR>1.3) not due to a reversible cause. - Contra-indication to performance of a MRI scan. - Recipients of organ transplant. - Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years). - Non-cardiac condition that limits lifespan <1 year. - On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFa antagonist. - Patients allergy to or cannot use immunosuppressant. - Serum positive for HIV, HBV, HCV, TP. - Currently enrolled other investigational therapeutic or device study. - Patients who are pregnant or breast feeding. - Other conditions that researchers consider not suitable to participate in this study. |
Country | Name | City | State |
---|---|---|---|
China | The second xiangya hospital of central south university | Changsha | Hunan |
China | HelpThera | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Help Therapeutics | Central South University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety in terms of the incidence and severity of adverse events | Number of participants with death, fatal myocardial infarction, stroke, ventricular tachycardia sustained for >15 seconds and newly formed tumor | within 1 month post CABG surgery | |
Secondary | Incidence of adverse events | Adverse events that require medical intervention | 1~6 months post CABG surgery | |
Secondary | Cardiac assessment | 24-hour Holter Monitoring post the CABG surgery | 1~6 months post CABG surgery | |
Secondary | Incidence of newly formed tumor | Evaluation by chest, abdominal and pelvic CT scan and PET-CT scan | 1~12 months post CABG surgery | |
Secondary | Immunogenic assessments | Donor specific antibody (DSA), serum anti-human leukocyte antigens (anti-HLA) antibody/panel-reactive antibody (PRA) serology monitoring | 1 month, 3 months and 6 months post CABG surgery | |
Secondary | Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI | Changes in cardiac function will be assessed by left ventricular end-systolic volume (LVESV, mL) changes from baseline to 12 months post surgery | from baseline to 12 months at 3, 6, and 12 months post CABG surgery | |
Secondary | Changes in 6-minute walk test (6MWT) | from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery | ||
Secondary | Changes in NYHA functional classification | from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery | ||
Secondary | Changes in quality of life (QoL) | Quality of life changes as measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores | from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery | |
Secondary | Incidence of hospitalization for worsening heart failure | 1~12 months post CABG surgery |
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