The purpose of this clinical study is to evaluate the safety and efficacy of endocardial delivery of HS-001 CS into severe heart failure patients with reduced ejection fraction for 26 weeks after transplantation.
Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on screening echocardiographic assessment
New York Heart Association (NYHA) cardiac function classification of grade II or III at screening
Other Criteria apply, please contact the investigator
Patients with cardiac devices such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resuscitation-enabled implantable cardioverter defibrillators (CRT-Ds)
Patients with heart failure due to the primary disease hypertrophic cardiomyopathy (including the dilated phase), restrictive cardiomyopathy, amyloidosis, takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis
Other Criteria apply, please contact the investigator
Single group
HS-005
Combination productHuman (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems
Safety and Tolerability
Adverse events and safety in the 26 weeks after HS-005 administration
Left Ventricular Ejection Fraction in Cardiac MRI scan
Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Left Ventricular Ejection Fraction in Echocardiography
Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Left Ventricular volume in Cardiac MRI scan
Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
Left Ventricular volume in Echocardiography
Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
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