Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on screening echocardiographic assessment
- New York Heart Association (NYHA) cardiac function classification of grade II or III at screening
- Other Criteria apply, please contact the investigator
Exclusion Criteria:
- Patients with cardiac devices such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resuscitation-enabled implantable cardioverter defibrillators (CRT-Ds)
- Patients with heart failure due to the primary disease hypertrophic cardiomyopathy (including the dilated phase), restrictive cardiomyopathy, amyloidosis, takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis
- Other Criteria apply, please contact the investigator
