Positive results have been announced from a phase 2b trial of ixmyelocel-T (Vericel Corporation) in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The study met its primary endpoint of demonstrating a reduction in the total number of deaths, cardiovascular hospitalizations, or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months after treatment with ixmyelocel-T compared with placebo.
The incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable with that in patients in the placebo group.
Ixmyelocel-T is a patient-specific, expanded multicellular therapy manufactured from the patient’s own bone marrow using a proprietary, automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells or, alternatively, activated macrophages, which are responsible for the production of anti-inflammatory and pro-angiogenic factors known to be important for the repair of damaged tissue. Ixmyelocel-T received an orphan drug designation from the FDA for use in the treatment of DCM.
The ixCELL-DCM trial was a randomized, double-blind, placebo-controlled phase 2b study designed to assess the efficacy, safety, and tolerability of ixmyelocel-T compared with that of placebo (vehicle control) when administered via transendocardial catheter-based injections to subjects with end-stage heart failure due to ischemic DCM who had no reasonable revascularization options (either surgical or percutaneous interventional) that were likely to provide a clinical benefit. A total of 114 patients were treated at 28 sites in the U.S.
Source: Vericel Corporation; March 10, 2016.