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.
This is a multicenter, open-label, phase I/II study in 14 severe heart failure patients with reduced ejection fraction. After screening period is completed, subjects undergo HS-001 CS transplantation by endocardial delivery. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Human (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
Time frame: 26 weeks post-transplant
Left Ventricular Ejection Fraction in Cardiac MRI scan
Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Time frame: 26 weeks and 52 weeks post-transplant
Left Ventricular Ejection Fraction in Echocardiography
Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
Time frame: 26 weeks and 52 weeks post-transplant
Left Ventricular volume in Cardiac MRI scan
Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
Time frame: 26 weeks and 52 weeks post-transplant
Left Ventricular volume in Echocardiography
Left Ventricular volume in the 26 weeks and 52 weeks after HS-005 administration
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial wall motion evaluation in MRI
Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial wall motion evaluation in Echocardiography
Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant
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Myocardial blood flow in SPECT
Myocardial blood flow in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial viability in SPECT
Myocardial viability in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant
6-minute walk distance
6-minute walk distance in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NT-proBNP measurement in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant
QoL questioner (Kansas City Cardiomyopathy Questionnaire)
KCCQ evaluation in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant
QoL questioner (EuroQol 5 dimensions 5-level)
EQ-5D-5L evaluation in the 26 weeks and 52 weeks
Time frame: 26 weeks and 52 weeks post-transplant