A Randomized, Open-label, Multicenter Trial for the Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction
Overview
- Phase
- Phase 2
- Intervention
- Mesenchymal stem cell
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Yonsei University
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Absolute changes in global LVEF by SPECT
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (MI) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. Current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but only one clinical trial using MSCs via the intracoronary route in the setting of acute myocardial infarction (AMI) has been carried out. The investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in patients with AMI.
Investigators
Eligibility Criteria
Inclusion Criteria
- •aged 18-70 years
- •ischemic chest pain for \>30 min
- •admitted to hospital \<24 h after the onset of chest pain
- •electrocardiography showed ST segment elevation \>1 mm in two consecutive leads in the limb leads or \>2 mm in the precordial leads
- •they could be enrolled in the study \<72 h after successful revascularization
Exclusion Criteria
- •cardiogenic shock (defined as systolic blood pressure \<90 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation)
- •life-threatening arrhythmia
- •impossible conditions for cardiac catheterization
- •advanced renal or hepatic dysfunction
- •history of previous coronary artery bypass graft
- •history of hematologic disease
- •history of malignancy
- •major bleeding requiring blood transfusion
- •stroke or transient ischemic attack in the previous 6 months
- •structural abnormalities of the central nervous system (brain tumor, aneurysm, history of surgery)
Arms & Interventions
Mesenchymal stem cell treatment group
Intervention: Mesenchymal stem cell
Control group
All patients were required to have successful revascularization of an infarct-related artery on coronary angiography at the time of randomization. All patients received aspirin (300 mg loading dose, then 100 mg daily) and clopidogrel (600 mg loading dose, then 75 mg daily) with optimal medical therapy according to the American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines for treatment of ST-segment elevation myocardial infarction (STEMI)
Intervention: Control group
Outcomes
Primary Outcomes
Absolute changes in global LVEF by SPECT
Time Frame: baseline and 6 months
Absolute changes in global left ventricular ejection fraction (LVEF) as measured by SPECT 6 months after cell infusion
Secondary Outcomes
- Changes in left ventricular end-diastolic volume (LVEDV)(baseline and 6 months)
- Changes in left ventricular end-systolic volume (LVESV)(baseline and 6 months)
- Changes in regional wall motion score index (WMSI) by Echocardiography(baseline and 6 months)
- Major adverse cardiac event (MACE)(6 months)