Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in AMI Patients (TEAM-AMI)
Myocardial Infarction, Stem Cell Transplantation, Angioplasty, Transluminal, Percutaneous Coronary
About this trial
This is an interventional treatment trial for Myocardial Infarction
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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
Experimental
Phase A: Atorvastatin
Phase A: Low dose BMMSC
Phase A: Middle dose BMMSC
Phase A: High dose BMMSC
Phase B: Atorvastatin
Phase B: Atorvastatin+Transplantation
Phase B: Intensive Atorvastatin
Phase B: Intensive Atorvastatin+Transplantation
Atorvastatin routine dose + placebo transplantation
Atorvastatin routine dose + low dose BMMSC Transplantation
Atorvastatin routine dose + middle dose BMMSC Transplantation
Atorvastatin routine dose + high dose BMMSC Transplantation
Atorvastatin routine dose + placebo transplantation
Atorvastatin routine dose+ Optimal dose BMMSC Transplantation
Atorvastatin Intensive dose + placebo transplantation
Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation