NCT00289822终止2 期
Cell Therapy for Coronary Heart Disease: Infusion of Autologous Ex Vivo Cultivated Endothelial Progenitor Cells (EPCs)" and Autologous Bone Marrow Progenitor Cells in Crossover Design for Improvement of Vascularization and Cardiac Function
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in global left ventricular function (measured by quantitative left ventricular angiography)
研究概览
简要总结
Impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy.
The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (>= 3 months) myocardial infarction.
详细描述
- The study is an open-label, controlled, randomized single-center trial.
- Patients post myocardial infarction (>= 3 months) with a patent infarct-related artery are included.
- Bone marrow-derived progenitor cells are aspirated under local anaesthesia, and after cell processing, are infused into the patent infarct-related artery during stop flow within the same day. Blood-derived progenitor cells are isolated out of 250ml peripheral venous blood, and after cell processing and 3 days culture, are infused into the patent infarct-related artery during stop flow. In addition, left ventricular angiography is performed. In the control group coronary angiography and left ventricular angiography without any intracoronary infusion are performed.
- After 3 months, left ventricular angiography is repeated, and patients of the control group cross-over to active treatment with progenitor cells, whereas patients initially treated with progenitor cells cross-over to the alternate cell type.
- The primary endpoint is the change in quantitative global left ventricular ejection fraction in LV angiography between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80
- •Patients post-myocardial infarction (> 3 months old) or with diffuse ischemic CHD
- •Signed informed consent
排除标准
- •- Existing neoplastic disease or signs of tumor recurrence within the last 5 years
- •Active infection
- •Active internal bleeding
- •Stroke within the past 2 years
- •Surgery or trauma within the past two months
- •Uncontrolled hypertension over 160/100
- •Arteriovenous malformations or aneurysms
- •HIV infection
- •Signs of significant kidney or liver failure (creatinine > 2.0 mg/dL, GOT > 2 x upper standard value)
- •Thrombopenia (< 100,000)
- •Anemia (hemoglobin < 8.5 g/dL)
- •Mental retardation
- •Participation in another clinical study
- •Women of childbearing age
- •Chronic inflammatory disease
结局指标
主要结局
Change in global left ventricular function (measured by quantitative left ventricular angiography)
次要结局
- Quantitative parameters of regional left ventricular function of the target area
- changes in left ventricular volumes
- functional status as assessed by NYHA classification
- event-free survival after 4 months follow-up
研究者
研究点 (2)
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