NCT00620048终止1 期
Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%
Losordo, Douglas, M.D.2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Safety of intramyocardial administration of CD34-positive cells
研究概览
简要总结
The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 21 to 80 years old (inclusive).
- •Subjects with functional class (NYHA) II or III ischemic heart failure.
- •Subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme (ACE)inhibitors without control of symptoms.
- •Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
- •Subjects must have left ventricular ejection fraction <40% by echocardiography.
- •All subjects must have a recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures.
- •Have serum B-type Natriuretic Peptide (BNP) level >100 pg/ml.
排除标准
- •Myocardial infarction (Q wave or non-Q wave defined as CKMB >3 times normal) within 30 days of treatment.
- •Successful coronary revascularization procedures within 3 months of study enrollment.
- •Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
- •NYHA Class IV heart failure and patients with idiopathic or non-ischemic heart failure.
- •History of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency (>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+).
- •Implantation of biventricular pacemaker within 90 days of study treatment.
- •Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).
结局指标
主要结局
Safety of intramyocardial administration of CD34-positive cells
时间窗: 6 months
次要结局
- Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes.(6 months)
研究者
研究点 (2)
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