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
Overview
- Phase
- Phase 2
- Intervention
- Middle dose BMMSC
- Conditions
- Myocardial Infarction
- Sponsor
- Yuejin Yang
- Enrollment
- 124
- Primary Endpoint
- Changes in left ventricular ejection fraction from baseline to 12 months'
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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. MRI evaluates function of the heart chambers the beating motion of the muscle.
Investigators
Yuejin Yang
Vice Dean of Fuwai hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Phase A: Middle dose BMMSC
Atorvastatin routine dose + middle dose BMMSC Transplantation
Intervention: Middle dose BMMSC
Phase A: Atorvastatin
Atorvastatin routine dose + placebo transplantation
Intervention: Atorvastatin
Phase A: Low dose BMMSC
Atorvastatin routine dose + low dose BMMSC Transplantation
Intervention: Atorvastatin
Phase A: Low dose BMMSC
Atorvastatin routine dose + low dose BMMSC Transplantation
Intervention: Low dose BMMSC
Phase A: Middle dose BMMSC
Atorvastatin routine dose + middle dose BMMSC Transplantation
Intervention: Atorvastatin
Phase A: High dose BMMSC
Atorvastatin routine dose + high dose BMMSC Transplantation
Intervention: Atorvastatin
Phase A: High dose BMMSC
Atorvastatin routine dose + high dose BMMSC Transplantation
Intervention: High dose BMMSC
Phase B: Atorvastatin
Atorvastatin routine dose + placebo transplantation
Intervention: Atorvastatin
Phase B: Atorvastatin+Transplantation
Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
Intervention: Atorvastatin
Phase B: Atorvastatin+Transplantation
Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
Intervention: Transplantation
Phase B: Intensive Atorvastatin
Atorvastatin Intensive dose + placebo transplantation
Intervention: Intensive Atorvastatin
Phase B: Intensive Atorvastatin+Transplantation
Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
Intervention: Intensive Atorvastatin
Phase B: Intensive Atorvastatin+Transplantation
Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation
Intervention: Transplantation
Outcomes
Primary Outcomes
Changes in left ventricular ejection fraction from baseline to 12 months'
Time Frame: 12 months
Changes in left ventricular ejection fraction from baseline to 12 months' by MRI