Abstract 14006: Selected CD133+ Endothelial Progenitor Cells to Create Angiogenesis in Patients With Refractory Angina. Final Results of the PROGENITOR Trial
Aims: The aim of this study was to assess the safety and the feasibility of transendocardial injection of selected CD133+ cells in patients with refractory angina.
Methods and Results: the PROGENITOR trial is a randomized, blinded, multicenter controlled trial. Patients with II-IV angina functional class with ischemia by SPECT, without any options for revascularization were randomized (2:1) to receive either transendocardial injection of selected CD133+ or no treatment. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+ cells. Secondary endpoints included the efficacy. All patients were treated for 4 days with G_CSF, underwent an apheresis. CD133+ cells were selected with CliniMacs system (Miltenyi Biotec). In patients allocated to cell therapy, CD133+ cells were injected transendocardially with the NOGA XP system. A total of 28 patients were included. The mean age was 64±9 years, 85% were male. The mean dose of injected cells was 29.6±1.4x106 with 82.8 %of CD133+ purity. At 6-months one patient in each group suffered from ventricular fibrillation and 1 patient in from each group died. One patient from the treatment group had a cardiac tamponade during mapping. At 6 months, the number of angina episodes/month significantly reduced in the cell group (Baseline: 12.8±8.7 vs 6-month: 3.2±3.9;p=0.001). However, no significant changes were observed in the control group (Baseline: 7.8±3.2 vs 6-month: 9.4±12.8;p=0.7). Similarly, the Canadian cardiovascular society significantly improved in the treatment group at 6 months (2.7±0.4 vs. 1.7±0.7;p=0.001) whereas remained unchanged in the control group (2.7±0.4 vs. 2.2±0.7;p=0.1). At 6 months the total rest and stress severity scores by SPECT showed significant improvement in the cell group [rest: (22.6±6.3 vs 22.0±6.2;p=0.01); stress: (26.1±2.4 vs 24.8±7.0;p=0.009)] and no significant changes in the control group [rest: (18.7±6.3 vs 18.6±2.2;p=0.3); stress: (22.1±5.1 vs21.7±5.4;p=0.2).
Conclusions: this is the first-in-man trial with transendocardial injection of selected CD133+ cells in patients with refractory angina. These results suggest the safety and feasibility of the procedure and show promising positive results in terms of efficacy.
- © 2013 by American Heart Association, Inc.