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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | HS-005 administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-005 | Combination Product | Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids (HS-001CS) transplantation with endocardial delivery systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Adverse events and safety in the 26 weeks after HS-005 administration | 26 weeks post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction in Cardiac MRI scan | Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration | 26 weeks and 52 weeks post-transplant |
| Left Ventricular Ejection Fraction in Echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heartseed Inc. | Contact | +8163801068 | contact@heartseed.jp |
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Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-005 administration
| 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 | 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 | 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 | 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 | 26 weeks and 52 weeks post-transplant |
| Myocardial blood flow in SPECT | Myocardial blood flow in the 26 weeks and 52 weeks | 26 weeks and 52 weeks post-transplant |
| Myocardial viability in SPECT | Myocardial viability in the 26 weeks and 52 weeks | 26 weeks and 52 weeks post-transplant |
| 6-minute walk distance | 6-minute walk distance in the 26 weeks and 52 weeks | 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 | 26 weeks and 52 weeks post-transplant |
| QoL questioner (Kansas City Cardiomyopathy Questionnaire) | KCCQ evaluation in the 26 weeks and 52 weeks | 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 | 26 weeks and 52 weeks post-transplant |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D017202 | Myocardial Ischemia |
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D006332 | Cardiomegaly |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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