NCT05566600招募中早期 1 期
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
Help Therapeutics2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年10月9日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Safety in terms of the incidence and severity of adverse events
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery.
After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
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
- None
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).
- •Signed the Informed Consent Form (ICF).
- •Have chronic left ventricular dysfunction.
- •Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
- •Have indications for Coronary Artery Bypass Grafting.
- •LVEF < 40% as determined by echocardiogram (data collected up to 6 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 TNFα 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
Safety in terms of the incidence and severity of adverse events
时间窗: within 1 month post CABG surgery
Number of participants with death, fatal myocardial infarction, stroke, ventricular tachycardia sustained for \>15 seconds and newly formed tumor
次要结局
- Changes in NYHA functional classification(from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery)
- Changes in quality of life (QoL)(from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery)
- Cardiac assessment(1~6 months post CABG surgery)
- Incidence of newly formed tumor(1~12 months post CABG surgery)
- Immunogenic assessments(1 month, 3 months and 6 months post CABG surgery)
- Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI(from baseline to 12 months at 3, 6, and 12 months post CABG surgery)
- Incidence of hospitalization for worsening heart failure(1~12 months post CABG surgery)
- Incidence of adverse events(1~6 months post CABG surgery)
- Changes in 6-minute walk test (6MWT)(from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery)
研究者
研究点 (2)
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