Novel Cell Therapy Cuts Clinical Events in Advanced HF

Patrice Wendling

March 14, 2016

CAMBRIDGE, MA — Ixmyelocel-T met its primary end point in patients with end-stage heart failure due to ischemic dilated cardiomyopathy in the ixCELL-DCM trial, its maker, Vericel, announced[1].

Transendocardial catheter-based injections of ixmyelocel-T reduced the number of deaths, cardiovascular hospitalizations, or unplanned outpatient and emergency-department visits to treat acute decompensated heart failure compared with placebo in the 12 months following treatment.

The incidence of adverse events, including serious events, was comparable between the study arms.

The phase 2b study, conducted in 114 patients at 28 US sites, is thought to be the largest randomized cell-therapy trial to treat congestive heart failure completed to date.

Full results from the trial will be presented in a late-breaking clinical abstract session April 4 at the American College of Cardiology 2016 Scientific Sessions in Chicago.

Ixmyelocel-T is an autologous bone-marrow–derived cellular therapy that uses expanded populations of mesenchymal stromal cells and alternately activated macrophages. It has been granted orphan drug status by the US Food and Drug Administration for the treatment of dilated cardiomyopathy.

The study was funded by Vericel. 

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