Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting (CABG): A Randomized Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction at rest, measured by gated SPECT
研究概览
简要总结
One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis which due to congestive heart failure.
One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function.
The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.
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
- •CABG candidate
- •At least 4 akinetic segments
- •First anterior heart attack within in 10 days to 3 month.
- •St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography.
- •The target lesion had to be located in the left anterior descending (LAD) section.
排除标准
- •History of prior anterior myocardial infarction:
- •History of prior CABG
- •Poor echocardiography window.
- •Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l
- •Documental terminal illness or malignancy.
- •Previous bone marrow transplant
- •Autoimmune disease (e. g Lupus, Multiple sclerosis)
- •Any contraindication for bone - marrow aspiration.
- •Positive pregnancy test (in women with child bearing potential)
结局指标
主要结局
Left ventricular ejection fraction at rest, measured by gated SPECT
时间窗: 6 months
次要结局
- changes in LVM index, LVEDV, LVESV(6 months)
- Regional contractility in the AOI / Change in LV dimensions (left ventricular end systolic diameter [LVESD], left ventricular end diastolic diameter [LVEDD]) as assessed by echocardiography(6 months)