Treating Heart Failure With hPSC-CMs

Patients with heart failure will be treated with allogenic human pluripotent stem cell-derived cardiomyocytes ( hPSC-CM ) from healthy donors. The cells will be injected directly into the myocardium at time of coronary artery bypass grafting. Patients will be assessed at 1, 6 and 12 months after cell transplantation for safety, feasibility and efficacy.

Inclusion criteria

• Aged 35-75 (including 35 and 75).
• Have signed the Informed Consent Form (ICF).
• Patients have chronic left ventricular dysfunction.
• Patients have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
• Patients have indications for Coronary Artery Bypass Grafting.
• 20% ≤ LVEF ≤ 45% 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 TNFα 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.