Abstract 14894: Percutaneous Intramyocardial Injection of Mesenchymal Stromal Cells in Patients with Severe Stable Coronary Artery Disease and Refractory Angina: Final 3 Year Follow-Up
Introduction Regenerative therapy with stem cells is an emerging treatment modality for patients with coronary artery disease (CAD). This study assessed long-term safety and efficacy of percutaneous intramyocardial injection of autologous bone-marrow derived mesenchymal stromal cells (MSC) in patients with severe stable CAD and refractory angina.
Hypothesis That treatment was safe and that patients would experience reduced symptom burden.
Methods Thirty-one patients with severe stable CAD and refractory angina were included. Patients had reversible myocardial ischemia and no further revascularization options. Autologous bone-marrow MSCs were isolated, culture expanded and stimulated with vascular endothelial growth-factor to facilitate endothelial differentiation. MSCs were injected into an ischemic, viable region of the myocardium using the electromechanical NOGA® system. Patients were followed for 3 years.
Results We found significant and sustained clinical improvements. Angina class (CCS) improved from 3.0 ± 0.3 to 0.9 ± 1.0 (p > 0.001). Weekly number of angina attacks was reduced from 13.8 ± 13.7 to 4.3 ± 7.3 (p > 0.001) and weekly use of nitroglycerine was reduced from 10.7 ± 10.0 to 4.5 ± 6.8 (p > 0.001). In the Seattle Angina Questionnaire there were significant improvements (all p > 0.001) in physical limitation score, angina stability score, angina frequency score and quality of life score. Exercise time increased from 6:23 ± 1:43 to 7:00 ± 2:12 minutes, but the increase was no longer significant (p = 0.12), as it was seen after 6, 12 and 24 months. No early or late side-effects of the treatment were observed.
Conclusions These final 3-year follow-up data after percutaneous intramyocardial injection of autologous MSCs, in patients with severe CAD and refractory angina, demonstrated sustained and significantly positive clinical effects and the treatment was safe.
- © 2012 by American Heart Association, Inc.