OBJECTIVE: Bone marrow-derived adult stem cells may be able to regenerate infarcted myocardium. We initiated a phase-I study of autologous stem cell transplantation in patients undergoing coronary artery bypass grafting. METHODS: Inclusion criteria were: acute myocardial infarction > 10 days ago; presence of a distinct area of infarcted and akinetic myocardium; CABG indicated to treat ischemia of other LV wall areas. Stem cells were isolated from bone marrow using a ferrite-conjugated AC133 antibody, and were injected in the infarct border zone during the CABG operation. RESULTS: To date, 12 patients were treated without major complications. There is no evidence of new ventricular arrhythmia or neoplasia. Scintigraphic imaging demonstrated significantly improved local perfusion in the stem cell-treated infarct area. LV dimensions (LVEDV 140 +/- 38 ml vs. 124 +/- 30 ml, p = 0.004, paired t-test) and LV ejection fraction (39.7 +/- 9 % vs. 48.7 +/- 6 %, p = 0.007) have improved. CONCLUSIONS: Bone marrow stem cell transplantation for myocardial regeneration can be safely performed in humans. There is evidence of improved revascularization and contractility of infarct areas, but controlled studies are needed to clearly determine the clinical benefit.
OBJECTIVE: Bone marrow-derived adult stem cells may be able to regenerate infarcted myocardium. We initiated a phase-I study of autologous stem cell transplantation in patients undergoing coronary artery bypass grafting. METHODS: Inclusion criteria were: acute myocardial infarction > 10 days ago; presence of a distinct area of infarcted and akinetic myocardium; CABG indicated to treat ischemia of other LV wall areas. Stem cells were isolated from bone marrow using a ferrite-conjugated AC133 antibody, and were injected in the infarct border zone during the CABG operation. RESULTS: To date, 12 patients were treated without major complications. There is no evidence of new ventricular arrhythmia or neoplasia. Scintigraphic imaging demonstrated significantly improved local perfusion in the stem cell-treated infarct area. LV dimensions (LVEDV 140 +/- 38 ml vs. 124 +/- 30 ml, p = 0.004, paired t-test) and LV ejection fraction (39.7 +/- 9 % vs. 48.7 +/- 6 %, p = 0.007) have improved. CONCLUSIONS: Bone marrow stem cell transplantation for myocardial regeneration can be safely performed in humans. There is evidence of improved revascularization and contractility of infarct areas, but controlled studies are needed to clearly determine the clinical benefit.