Heart Failure, Ischemic Heart Disease
Conditions
Keywords
Heart Failure, Ischemic Heart Disease
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHS-001 CS
Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension
DEVICEHS-001-D needle, HS-001-D Adaptor
Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors
Sponsors
Heartseed Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on either screening cardiac MRI or echocardiographic assessment * New York Heart Association (NYHA) cardiac function classification of grade II or higher at screening * Other Criteria apply, please contact the investigator
Exclusion criteria
* Patients screened less than 1 month after the onset of myocardial infarction * Patients with congenital heart disease, or cardiac sarcoidosis * Other Criteria apply, please contact the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 26 weeks post-transplant | Adverse events and safety in the 26 weeks after HS-001 CS transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 26 weeks and 52 weeks post-transplant | Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| 5-level EQ-5D version (EQ-5D-5L) | 26 weeks and 52 weeks post-transplant | 5-level EQ-5D version (EQ-5D-5L) in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography | 26 weeks and 52 weeks post-transplant | Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| 6-minute walk distance | 26 weeks and 52 weeks post-transplant | 6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| Myocardial blood flow in SPECT | 26 weeks and 52 weeks post-transplant | Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| Myocardial viability in SPECT | 26 weeks and 52 weeks post-transplant | Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | 26 weeks and 52 weeks post-transplant | N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| Myocardial wall motion evaluation in Echocardiography | 26 weeks and 52 weeks post-transplant | Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks after HS-001 CS transplantation |
Countries
Japan
Outcome results
None listed