Abstract 14310: Selected Cd133+ Endothelial Progenitor Cells to Create Angiogenesis in No-Option Patients. Preliminary 3-Months Results of the Progenitor Trial
Background and Objective: CD133+ progenitor cells are considered an immature population with the capacity to differentiate into endothelial cells. The aim of this study was to assess the safety and the feasibility of transendocardial injection of selected CD133+ cells in patients (pts) with refractory angina without any option of revascularization.
Methods: PROGENITOR trial is a randomized, blinded, multicenter controlled trial. Pts with class II-IV angina and with ischemic/viable zone demonstrated with SPECT without any option of revascularization were included. All Pts were treated for 4-days with G-CSF and underwent an apheresis to isolate the cells from the peripheral blood. CD133+ cells were selected with CliniMacs system (Miltenyi Biotec) and were injected transendocardially guided by the NOGA system. Their functionality was assessed with quantification of CFU after 7-days culture in fibronectin plates. A proliferation assay (BrdU incorporation into DNA, Amersham) and an apoptosis assay (DNA fragmentation, Roche) were performed. Microtubule formation capacity was studied with Matrigel and aldehyde-dehydrogenase (ALDH) expression was assessed with the ALDEFLUOR kit.
Results: 28 pts have been included. Mean age was 64±9, 85% were male, 53% were diabetics. Cell dose was 30 millions. CD45low 99.95±0.11%; CD133+ 82.42±10.3%; Mean CFU was 19.9±20.0. Proliferation and apoptosis rates -when compared to mononuclear fraction-were 0,86 and 0,98, respectively. ALDH expression was >80% and microtubules formation was observed in all pts. Clinical fu: 1 pt from the placebo group suffered ventricular fibrillation 24-hours after the baseline procedure and an ICD was implanted. This pt died at 3.5 months due to a cardiovascular cause. One pt from the treatment group presented VT during the injection that was successfully cardioverted. One pt from the treatment group had a cardiac tamponade during mapping that was revolved, but the pt died due to cardiogenic shock. No more events were recorded..
Conclusions: this is the first-in-man trial with transendocardial injection of selected CD133+ cells in no-option pts. To date, these results suggest the safety and feasibility of the procedure. Efficacy results at 3-months will be presented at the congress.
- © 2012 by American Heart Association, Inc.