The Randomized Double-blind Placebo-Controlled Multi-center Clinical Trial of Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in Acute Myocardial Infarction Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 124
- 主要终点
- Changes in left ventricular ejection fraction from baseline to 12 months'
研究概览
简要总结
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after acute myocardial infarction who underwent intracoronary transfer of autologous bone marrow mesenchymal stem cells.
详细描述
The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells, autologous bone marrow mesenchymal stem cells transplantation. Patients between 30 and 75 years of age who receive autologous bone marrow mesenchymal stem cells transplant may be eligible for this study. These patients receive autologous bone marrow mesenchymal stem cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.
Heart function tests may include the following:
Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the first time ST-elevation myocardial infarction (STEMI).
- •Patients after undergoing PCI 2 to 5 days.
- •Patients without PCI but emergency coronary angiography shows the criminal coronary artery recanalized.
- •Left ventricular infarction area seriously hypokinesis or no movement
- •Left ventricular ejection fraction <=45% based on coronary angiography or echocardiography.
排除标准
- •Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- •Patients without emergency PCI and the criminal coronary artery fail to be recanalized.
- •Patients with non-ST-elevation myocardial infarction.
- •Patients with normal left ventricular function.
- •Patients with mechanical complications of myocardial infarction.
- •Patients with a malignant tumor.
- •Patients with infection disease.
- •Less than 6 months since last episode of stroke.
- •Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- •ALT (GPT) exceeding 100 IU/L.
- •Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- •Platelets less than 100,000/µL.
- •Hemoglobin less than 10 g/dL.
- •Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- •Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
研究组 & 干预措施
Phase A: Middle dose BMMSC
Atorvastatin routine dose + middle dose BMMSC Transplantation
干预措施: Middle dose BMMSC (Drug)
Phase A: Atorvastatin
Atorvastatin routine dose + placebo transplantation
干预措施: Atorvastatin (Drug)
Phase A: Low dose BMMSC
Atorvastatin routine dose + low dose BMMSC Transplantation
干预措施: Atorvastatin (Drug)
Phase A: Low dose BMMSC
Atorvastatin routine dose + low dose BMMSC Transplantation
干预措施: Low dose BMMSC (Drug)
Phase A: Middle dose BMMSC
Atorvastatin routine dose + middle dose BMMSC Transplantation
干预措施: Atorvastatin (Drug)
Phase A: High dose BMMSC
Atorvastatin routine dose + high dose BMMSC Transplantation
干预措施: Atorvastatin (Drug)
Phase A: High dose BMMSC
Atorvastatin routine dose + high dose BMMSC Transplantation
干预措施: High dose BMMSC (Drug)
Phase B: Atorvastatin
Atorvastatin routine dose + placebo transplantation
干预措施: Atorvastatin (Drug)
Phase B: Atorvastatin+Transplantation
Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
干预措施: Atorvastatin (Drug)
Phase B: Atorvastatin+Transplantation
Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
干预措施: Transplantation (Drug)
Phase B: Intensive Atorvastatin
Atorvastatin Intensive dose + placebo transplantation
干预措施: Intensive Atorvastatin (Drug)
Phase B: Intensive Atorvastatin+Transplantation
Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
干预措施: Intensive Atorvastatin (Drug)
Phase B: Intensive Atorvastatin+Transplantation
Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
干预措施: Transplantation (Drug)
结局指标
主要结局
Changes in left ventricular ejection fraction from baseline to 12 months'
时间窗: 12 months
Changes in left ventricular ejection fraction from baseline to 12 months' by MRI
次要结局
未报告次要终点
研究者
Yuejin Yang
Vice Dean of Fuwai hospital
Chinese Academy of Medical Sciences, Fuwai Hospital