NCT00810238已完成2 期
C-Cure - Safety, Feasibility and Efficacy of Guided Bone Marrow-derived Mesenchymal Cardiopoietic Cells for the Treatment of Heart Failure Secondary to Ischemic Cardiomyopathy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 15
- 主要终点
- Change in left ventricular ejection fraction
研究概览
简要总结
The purpose of this clinical trial is to evaluate the feasibility, safety and efficacy of left ventricular endocardial injection of guided bone marrow-derived cardiopoietic cells (C-Cure) in the setting of chronic heart failure secondary to ischemic cardiomyopathy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 and < 75 years old;
- •Subject has Heart Failure, New York Heart Association (NYHA) class II or class III with LVEF > 15% and ≤ 40% as assessed by transthoracic echocardiography;
- •Subject has ischemic heart disease;
- •Subject has an identifiable (by transthoracic echocardiography) area of transmural scar within the left ventricle;
- •Subject is on optimal and stable medical therapy for more than 2 months;
- •Subject is willing and able to undergo an ICD implantation, prior to receiving C-Cure™ or already has an ICD implanted;
- •Subject agrees to comply with all follow-up evaluations;
- •Subject has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent.
排除标准
- •Subject has been treated with cell-based therapy;
- •Subject has myocardial revascularization by PCI or CABG within 2 months prior to enrolment;
- •Subject has had an MI within 2 months prior to enrolment;
- •Subject is planned for PCI, CABG or any cardiac surgery;
- •Subject has received a biventricular pacemaker within 6 month prior to enrolment;
- •Subject has moderate to severe aortic valve heart disease, aortic or mitral prosthetic valve;
- •Subject has a significant mitral valve insufficiency (Effective Regurgitant Orifice (ERO) > 0.2 cm²) with possibility of mitral valve surgery;
- •Subject has left ventricular thrombus;
- •Subject has LV aneurysma or is a candidate for surgical aneurysmectomy;
- •Subject LV ventricular wall thickness is < 5 mm in the target territory;
- •Subject has proven high grade atrioventricular block or sustained ventricular tachyarrhythmias;
- •Subject has an hemodynamically significant congenital heart disorder;
- •Subject has clinical evidence for infection or active malignancy;
- •Subject has known stable chronic kidney dysfunction with serum creatinine > 2.5 mg/dL at two occasions during the screening period;
- •Subject has experienced severe adverse reaction/allergies to contrast agents;
- •Subject has atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree, that could impede or preclude the safe retrograde passage of the delivery catheter, in the judgment of the investigator;
- •Subject is on chronic immunosuppressive transplant therapy;
- •Subject had an autologous or allogenic bone marrow or peripheral stem cell transplant or prior solid organ transplantation;
- •Subject has a multisystem disease;
- •Subject has been tested positive for Human Immunodeficiency Virus (HIV 1 or HIV 2), Hepatitis B Virus (HBV), Hepatitis C (HCV) and/or syphilis;
- •Women of child bearing potential;
- •Subject has life expectancy < 1 year from non heart failure related causes;
- •Subject suffers from morbid obesity (Body Mass Index (BMI) > 40);
- •Subject has a recent history of alcohol or drug abuse;
- •Subject has any other surgical or medical condition that, in the judgment of the investigator might warrant exclusion or be contraindicated for safety reasons;
- •Subject is currently participating in another trial.
结局指标
主要结局
Change in left ventricular ejection fraction
时间窗: 6 months
次要结局
- 6-min walking distance(6 months, 1 and 2 years)
- Quality of Life(6 months, 1 and 2 years)
- All cause mortality(Each follow-up)
- Cardiovascular events(Each follow-up)
研究者
研究点 (15)
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