Monday, Mesoblast Limited (NASDAQ:MESO) announced that the FDA supports an accelerated approval pathway for rexlemestrocel-L, its allogeneic mesenchymal precursor cell product, for end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD).
In the placebo-controlled LVAD-MPC Study #2, 70 patients with end-stage ischemic HFrEF were randomized at the time of LVAD implantation surgery to either a single intervention with rexlemestrocel-L (150 million STRO3-immunoselected and culture-expanded allogeneic cells) or placebo injected directly into the left ventricular myocardium. Key findings were:
- Ischemic controls were characterized by persistently elevated levels of the ...