Overview
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.
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.
Eligibility
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
