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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-001 Low dose | Experimental | HS-001 Low dose Administration |
|
| HS-001 High dose | Experimental | HS-001 High dose Administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-001 CS | Biological | Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Adverse events and safety in the 26 weeks after HS-001 CS transplantation | 26 weeks post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 26 weeks and 52 weeks post-transplant |
| Myocardial wall motion evaluation in Echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Marianna University Hospital | Kawasaki | Japan | ||||
| Saitama Medical University International Medical Center |
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| HS-001-D needle, HS-001-D Adaptor | Device | Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors |
|
Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks after HS-001 CS transplantation |
| 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 | 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 | 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 | 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 | 26 weeks and 52 weeks post-transplant |
| 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 | 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 | 26 weeks and 52 weeks post-transplant |
| Saitama |
| Japan |
| Juntendo University Hospital | Tokyo | Japan |
| Nihon University Itabashi Hospital | Tokyo | Japan |
| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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