Abstract 19648: Effect of Transendocardial Delivery of Bone Marrow-Derived Cd133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final 12-Months Results of Randomized, Double-Blinded, Placebo-Controlled Regent-vsel Trial

Introduction: Refractory angina impairs the quality of life so new therapies are needed. Hypothesis: Transendocardial delivery of autologous bone marrow (BM)-derived CD133+ cells will improve perfusion and symptoms in patients with refractory angina. Methods: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent CCS II-IV angina despite optimal medical therapy, ≥ 1 myocardial segment with inducible ischemia in Tc-99m SPECT and no revascularization option who underwent BM biopsy and were allocated to cells (n=16) or placebo (n=15) group. Primary endpoint was the absolute change in myocardial ischemia by SPECT. Secondary end-points were LV function and volumes by MRI and angina severity. Secondary endpoints were quality of life (QoL), angina severity and ECG holter monitoring. Results: Primary endpoint: After 4 months there were no significant differences in extent of inducible ischemia between active and placebo arms [summed difference score (SDS) mean (±SD) 2.60 (2.6) vs. 3.63 (3.6), p=0.52; total perfusion deficit 3.60 (3.6) vs. 5.01 (4.3), p=0.32]; absolute changes of SDS [-1.38 (5.2) vs. -0.73 (1.9), p=0.65 and total perfusion deficit -1.33 (3.3) vs. -2.19 (6.6), p=0.65]. There was no significant change of LVEF in the cell group vs. placebo. Percentage of patients with improvement of symptoms after 1 (50% vs 54.6%, p=1.0) and 4 months (50% vs 33.3%, p=.62) was not significantly different between groups. Final results of 12-months follow-up of secondary endpoints will be presented. Conclusions: Transendocardial CD133+ cell therapy was safe and feasible. It did not provide significant reduction of myocardial ischemia measured by SPECT.