Background: Cell therapy has shown benefit in preclinical and clinical studies, although debate continues on the mechanism of action and the most appropriate methods for performing such therapies. We assessed the hypothesis that helical needle transendocardial (TE) delivery of autologous bone marrow (ABM) mononuclear cells around regions of hypo- or akinesia in patients after chronic myocardial infarction (MI) would be safe and possibly improve ejection fraction (EF).
Methods and results: Ten stable post-MI patients with an EF <40% were enrolled. Autologous bone marrow cells were aspirated from the iliac crest and delivered percutaneously with a TE helical needle catheter. A total of 86 x 10(6) cells were injected into 7.1 +/- 3.1 sites around the infarct to target the peri-infarct zones. Two-dimensional echocardiographic left ventricle EF measurements, 24-hour Holter, and exercise tolerance testing were performed at baseline, day of procedure, 1 and 12 weeks, and 6 and 12 months. There were no adverse events associated with the catheter-based cell transplantation procedure. At 6 and 12 months, all patients showed an improvement in left ventricle EF over baseline (35.2 +/- 4.6 to 40.8 +/- 4.5, P = .003 at 6 months; 35.2 +/- 4.6 to 42.3 +/- 5.1, P = .0001 at 12 months).
Conclusions: Autologous bone marrow cells delivered with the helical needle TE catheter was safe in this small uncontrolled study in patients with chronic MI. Increased EF and other positive data trends support continued development of this therapeutic strategy in larger controlled trials.