Abstract 15571: Effect of Cardiac Stem Cells in Patients with Ischemic Cardiomyopathy: Interim Results of the SCIPIO Trial
The heart contains c-kit+, lineage- cardiac stem cells (CSCs). Although CSCs improve postinfarction LV dysfunction in animals, their efficacy in humans is unknown. In February 2009, we began SCIPIO (Stem Cell Infusion in Patients with Ischemic CardiOmyopathy), a phase I, randomized, open-label trial of CSCs in patients with postinfarction LV dysfunction (EF <40%) who undergo CABG surgery. We isolate autologous CSCs from the right atrial appendage (harvested during CABG) and re-infuse them intracoronarily 4 ± 1 months after CABG; controls receive no treatment. Here we report the interim results after enrolling 17 CSC-treated and 7 control patients. In the 14 treated patients followed for 4 months, LVEF (3D echo) increased strikingly from 30.3 ± 1.9% before CSC infusion to 38.5 ± 2.8% 4 months later (P = 0.001) (Figure). This was associated with an improvement in regional wall motion score (echo) in the infused LV regions (1.97 ± 0.13 vs. 1.78 ± 0.12, P=0.007) as well as all segments (1.91 ± 0.09 vs. 1.73 ± 0.09, P=0.005), NHYA functional class (2.19 vs. 1.63, P=0.003) (Figure), and quality of life (Minnesota Heart Failure Questionnaire (MHFQ) (46.44 ± 5.22 vs. 26.69 ± 4.92, P<0.001). In contrast, in the 7 controls with 4 months of follow-up, none of these variables changed appreciably in this interval: LVEF, 30.1 ± 2.4% vs. 30.2 ± 2.5%, NYHA class, 2.00 vs. 1.71, and MHFQ score, 38.14 ± 10.53 vs. 40.43 ± 9.20. Importantly, the salubrious effects of CSCs noted at 4 months were even more pronounced at 1 year (e.g., LVEF increased by 12.3% vs. pre-CSC, P<0.001, n=8 [Figure]), suggesting that CSCs continue to improve LV function beyond 4 months. In the 7 treated patients in whom MRI could be performed, infarct size score decreased at 4 months (2.53 ± 0.22 vs. 2.21 ± 0.26, P=0.03). No adverse effects have been recorded. These initial results of CSC therapy in humans are very encouraging, and suggest that infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size.
- © 2011 by American Heart Association, Inc.