Intracoronary infusion of selected and unselected mononuclear cells does not lead to significant improvement in cardiac function after sustained ischemia: Results from the REGENT trial

September 2, 2008 by Katherine Ogando [mailto:kogando@perfuse.org]

ESC Congress 2008- Munich, DE: Intracoronary infusion of bone marrow-derived unselected mononuclear cell (MNC) and selected CD34+CXCR4+ cells does not lead to a significant improvement in left ventricular (LV) function, according to researchers from the Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Randomized Multicenter Trial.

The results were presented today at ESC 2008 Congress Hot Line session by Dr. Michal Tendera.

The use of cell therapy among patients with acute MI has been considered a promising treatment for poor LV function. The REGENT trial is the second largest trial applying cells drawn from bone marrow, with an enrollment of 200 acute MI patients with left ventricular ejection fraction (LVEF) ≤ 40%. This multicenter, randomized trial compared the effects of MNC and CD34+CXCR4+ cells on LVEF and volumes to a control population.

The primary endpoint of the trial was defined as change in LVEF and volumes as measured by MRI prior to and 6 months after the procedure.

The results demonstrated no significant difference in LVEF or volumes between patients receiving both selected and unselected cells and the control group. There was, however, a significant increase of 3% compared to baseline LVEF values among patients who received both types of cells. In addition, there was an improvement in cardiac function among patients with baseline EF values less than the median who received either MNC or CD34+CXCR4+ cells.

The rate of major cardiovascular events at 6 months was minimal, with no significant difference between the control group and the experimental group.

Although cell therapy with MNC and CD34+CXCR4+ cells was not associated with improved LVEF and volume, the REGENT trial results suggest a trend toward improved cardiac function in patients with poor baseline cardiac function using either selected or unselected bone marrow-derived cells. The trial also strengthened the notion that intracoronary infusion of bone marrow-derived cells is safe and feasible.

Reviewed by C. Michael Gibson, M.S., M.D.