NCT05223894招募中1 期
Epicardial Injection of Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
Help Therapeutics1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年6月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery.
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 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, 3, 6 and 12 months after cell transplantation for safety 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)
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
- •Aged 35-75 (including 35 and 75).
- •Have signed the Informed Consent Form (ICF).
- •Patients have chronic left ventricular dysfunction.
- •Patients have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
- •Patients have indications for Coronary Artery Bypass Grafting.
- •20% ≤ LVEF ≤ 40% as determined by echocardiogram (data collected up to 3 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid).
- •Weakening or absence of segmental regional wall motion as determined by standard imaging.
排除标准
- •PRA ≥ 20% or DSA-positive.
- •Patient received ICD transplantation, CRT or similar treatment.
- •Patients with valvular heart disease or received heart valvular disease
- •Patients received treatment of percutaneous transluminal coronary intervention (PCI)
- •Patients with atrial fibrillation
- •Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
- •Baseline glomerular filtration rate <30ml/min/1.73m
- •Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- •Hematological abnormality: A hematocrit <25% as determined by HCT, white blood cell<2500/ul or platelet values <100000/ul without another explanation.
- •Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
- •Coagulopathy (INR>1.3) not due to a reversible cause.
- •Contra-indication to performance of a MRI scan.
- •Recipients of organ transplant.
- •Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
- •Non-cardiac condition that limits lifespan <1 year.
- •On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNF-α antagonist.
- •Patients allergy to or cannot use immunosuppressant.
- •Serum positive for HIV, HBV, HCV, TP.
- •Currently enrolled other investigational therapeutic or device study.
- •Patients who are pregnant or breast feeding.
- •Other conditions that researchers consider not suitable to participate in this study.
结局指标
主要结局
Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery.
时间窗: 1 Month Post-operation
Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery. These include death, fatal myocardial infarction, stroke, cardiac tamponade, cardiac perforation, hemodynamic ventricular arrhythmias (duration \> 15s), and new allogeneic human neoplasms.
次要结局
- Cardiac output assessed by MRI(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Myocardium density assessed by MRI(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Overall Left Ventricular systolic performance as assessed by MRI(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Left ventricular mass assessed by MRI(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Size of infracted myocardium assessed by MRI(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Left Ventricular systolic performance as assessed by MRI(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Left ventricular ejection fraction assessed by MRI(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Left ventricular ejection fraction assessed by Echocardiogram(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Overall Left Ventricular systolic performance as assessed by Echocardiogram(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Mitral flow pattern (E/A) assessed by Echocardiogram(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Changes in penal reactive antibodies (PRA)(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Left Ventricular systolic performance as assessed by Echocardiogram(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Functional status by New York Heart Association (NYHA) Classification(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Minnesota Living With Heart Failure Questionnaire (MLHFQ)(Baseline, 1, 3, 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, 1, 3, 6 and 12 Months Post-operation)
- Incidence of Serious Adverse Events (SAE)(Baseline, 1~12Months Post-operation)
- Incidence of severe arrhythmia(First month post-operatively)
- Changes in donor specific antibodies (DSA)(Baseline, 1, 3, 6 and 12 Months Post-operation)
- Changes in cytokines(Baseline,1, 3, 6 and 12 Months Post-operation)
研究者
研究点 (1)
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