The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)
研究概览
简要总结
The aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor (G-CSF) treatment alone and in combination with vascular endothelial growth factor (VEGF) gene therapy in patients with severe chronic occlusive coronary artery disease.
详细描述
In recent clinical trials, vascular endothelial growth factor (VEGF) delivered as plasmid DNA percutaneously by a catheter-based, intramyocardial approach, have been demonstrated to be safe and to be associated with a reduction in angina and an increase in exercise time or an improvement in regional wall motion in "no-option patients" with chronic myocardial ischemia.
It has been demonstrated, that BM-derived stem cells mobilized by cytokines as granulocyte colony stimulating factor (G-CSF) were capable of regenerating the myocardial tissue, leading to improve the survival and cardiac function after myocardial infarction.
These data suggested that a combination therapy with exogenous administration of gene vascular growth factor combined with G-CSF mobilization of bone marrow stem cells might induce both angiogenesis and vasculogenesis in ischemic myocardium
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reversible ischemia at an adenosine stress single photon emission computerized tomography (SPECT)
- •A coronary arteriography demonstrating at least one main coronary vessel from which new collaterals/vessels could be supplied
- •Age above 18 years
- •Canadian Cardiovascular Society angina classification (CCS) > 3.
排除标准
- •Ejection fraction <0.40
- •Unstable angina pectoris
- •Acute myocardial infarction within the last three months
- •Diabetes mellitus with proliferative retinopathy
- •Diagnosed or suspected cancer disease
- •Chronic inflammatory disease
- •Premenopausal women
结局指标
主要结局
Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)
次要结局
- Clinical improvement