NCT07347197尚未招募1 期
A Phase I/II Study of Endocardial Delivery for Myocardial Regeneration Using Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids for Heart Failure Reduced Ejection Fraction
Heartseed Inc.0 个研究点目标入组 14 人开始时间: 2026年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
- 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 endocardial delivery of HS-001 CS into severe heart failure patients with reduced ejection fraction for 26 weeks after transplantation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 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
排除标准
- •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
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-005 administration
次要结局
- Left Ventricular Ejection Fraction in Cardiac MRI scan(26 weeks and 52 weeks post-transplant)
- Left Ventricular Ejection Fraction in Echocardiography(26 weeks and 52 weeks post-transplant)
- Left Ventricular volume in Cardiac MRI scan(26 weeks and 52 weeks post-transplant)
- Left Ventricular volume in Echocardiography(26 weeks and 52 weeks post-transplant)
- Myocardial wall motion evaluation in MRI(26 weeks and 52 weeks post-transplant)
- Myocardial wall motion evaluation in Echocardiography(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)
- 6-minute walk distance(26 weeks and 52 weeks post-transplant)
- N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)(26 weeks and 52 weeks post-transplant)
- QoL questioner (Kansas City Cardiomyopathy Questionnaire)(26 weeks and 52 weeks post-transplant)
- QoL questioner (EuroQol 5 dimensions 5-level)(26 weeks and 52 weeks post-transplant)
研究者
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