Bone Marrow Stem Cell Infusion Following a Heart Attack
Acute Myocardial Infarction
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Cell therapy
Eligibility Criteria
Inclusion Criteria: Patients age at least 21 years of age Patients with an acute anterior myocardial infarction limited to the proximal or mid-LAD with an artery diameter of at least 2.5 mm. Ability to undergo cell therapy procedure within 2 to 7 days following acute MI and PTCA/stenting. Ejection fraction following reperfusion with PTCA/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography. Consent to protocol and agree to comply with all follow-up visits and studies. Exclusion Criteria: History of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an ICD. Require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis > 70% luminal obstruction in the non-infarct related vessel. History of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ. History of anemia (Hb < 9.0 mg/dl). History of thrombocytosis. PT or PTT greater than the upper limits of normal. Life expectancy less than one year. Patients on chronic dialysis. History of untreated alcohol or drug abuse. Currently enrolled in another Investigational drug or device trial. History of stroke or TIA within the past 6 months. History of severe valvular heart disease (aortic valve area < 1.0 cm2 or > 3+ mitral regurgitation. Pregnancy Subjects who are HIV, hepatitis B or C positive. Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy. Contraindications to cardiac MRI
Sites / Locations
- Minneapolis Heart Institute Foundation
Arms of the Study
Arm 1
Experimental
Cell therapy
Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells.