Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of sustained ventricular arrhythmias
研究概览
简要总结
Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure.
详细描述
Patients with heart failure will be treated with allogenic human pluripotent stem cell-derived cardiomyocytes ( hPSC-CM ) from healthy donors. The cells will be injected directly into the myocardium at time of coronary artery bypass grafting. Patients will be assessed at 1, 6 and 12 months after cell transplantation for safety, feasibility and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
To ensure the study results are evaluated without bias, outcomes assessors will not be informed the randomization details.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
hPSC-CM Therapy
Procedure: Injection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 200 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.
干预措施: hPSC-CM Therapy (Biological)
Control
Procedure: Coronary artery bypass grafting surgery only.
干预措施: hPSC-CM Therapy (Biological)
结局指标
主要结局
Incidence of sustained ventricular arrhythmias
时间窗: 1~6 Month Post-operation
defined as the proportion of patients experiencing ventricular arrhythmias lasting more than 30 seconds
Incidence of newly formed tumors
时间窗: 1~12 Month Post-operation
by comparing chest, abdominal and pelvic CT scan and PET-CT scan
次要结局
- Overall Left Ventricular systolic performance as assessed by MRI(Baseline, 6 and 12 Months Post-operation)
- Overall Left Ventricular systolic performance as assessed by Echocardiogram(Baseline, 6 and 12 Months Post-operation)
- Overall Left Ventricular systolic performance as assessed by PET/ECT Scan(Baseline, 6 and 12 Months Post-operation)
- Functional status by 6 minute walk test(Baseline, 6 and 12 Months Post-operation)
- Functional status by New York Heart Association (NYHA) Classification(Baseline, 6 and 12 Months Post-operation)
- Minnesota Living With Heart Failure Questionnaire (MLHFQ)(Baseline, 1, 6 and 12 Months Post-operation)
- Incidence of Major Adverse Cardiac Events (MACE)(Baseline, 1~12 Months Post-operation)
- Incidence of Serious Adverse Events (SAE)(Baseline, 1~12 Months Post-operation)
- Changes in penal reactive antibodies (PRA)(Baseline, 1, 6 and 12 Months Post-operation)
- Changes in donor specific antibodies (DSA)(Baseline, 1, 6 and 12 Months Post-operation)
- Incidence of severe arrhythmia(First month post-operatively)
- Changes in cytokines(Baseline,1, 6 and 12 Months Post-operation)