A Phase I/II Study of Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Severe Heart Failure, Secondary to Ischemic Heart Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Safety and Tolerability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HS-001 Low dose
HS-001 Low dose Administration
干预措施: HS-001 CS (Biological)
HS-001 Low dose
HS-001 Low dose Administration
干预措施: HS-001-D needle, HS-001-D Adaptor (Device)
HS-001 High dose
HS-001 High dose Administration
干预措施: HS-001 CS (Biological)
HS-001 High dose
HS-001 High dose Administration
干预措施: HS-001-D needle, HS-001-D Adaptor (Device)
结局指标
主要结局
Safety and Tolerability
时间窗: 26 weeks post-transplant
Adverse events and safety in the 26 weeks after HS-001 CS transplantation
次要结局
- Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography(26 weeks and 52 weeks post-transplant)
- Myocardial wall motion evaluation in Echocardiography(26 weeks and 52 weeks post-transplant)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(26 weeks and 52 weeks post-transplant)
- Myocardial blood flow in SPECT(26 weeks and 52 weeks post-transplant)
- Myocardial viability in SPECT(26 weeks and 52 weeks post-transplant)
- N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)(26 weeks and 52 weeks post-transplant)
- 6-minute walk distance(26 weeks and 52 weeks post-transplant)
- 5-level EQ-5D version (EQ-5D-5L)(26 weeks and 52 weeks post-transplant)