The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.
This is a multicenter, open-label, two-group dose-escalation, phase I/II study in 10 severe heart failure patients (five in the low-dose group and five in the high-dose group) with underlying ischemic heart disease. After screening period is completed, subjects undergo HS-001 CS transplantation. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension
Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors
St. Marianna University Hospital
Kawasaki, Japan
Saitama Medical University International Medical Center
Saitama, Japan
Juntendo University Hospital
Tokyo, Japan
Nihon University Itabashi Hospital
Tokyo, Japan
Safety and Tolerability
Adverse events and safety in the 26 weeks after HS-001 CS transplantation
Time frame: 26 weeks post-transplant
Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography
Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-001 CS transplantation
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 after HS-001 CS transplantation
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial blood flow in SPECT
Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation
Time frame: 26 weeks and 52 weeks post-transplant
Myocardial viability in SPECT
Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation
Time frame: 26 weeks and 52 weeks post-transplant
6-minute walk distance
6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation
Time frame: 26 weeks and 52 weeks post-transplant
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation
Time frame: 26 weeks and 52 weeks post-transplant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Tokyo Hospital
Tokyo, Japan
Tokyo Medical and Dental University Medical Hospital
Tokyo, Japan
Tokyo Metropolitan Geriatric Medical Center
Tokyo, Japan
Tokyo Women's Medical University
Tokyo, Japan
5-level EQ-5D version (EQ-5D-5L)
5-level EQ-5D version (EQ-5D-5L) in the 26 weeks and 52 weeks after HS-001 CS transplantation
Time frame: 26 weeks and 52 weeks post-transplant
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in the 26 weeks and 52 weeks after HS-001 CS transplantation
Time frame: 26 weeks and 52 weeks post-transplant