Vericel Announces Positive Top-Line Results From Phase 2b ixCELL-DCM Clinical Trial of Ixmyelocel-T in Patients With Heart Failure Due to Ischemic Dilated Cardiomyopathy

Vericel Corporation (NASDAQ:VCEL) announced top-line results from the company’s Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM).
According to the news:

The trial 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 following treatment with ixmyelocel-T compared to placebo.  All clinical events in the primary and secondary endpoints were adjudicated in a blinded fashion by an independent adjudication committee.  The incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to patients in the placebo group.  Ixmyelocel-T has been granted orphan product designation by the U.S. Food and Drug Administration for use in the treatment of DCM.

Dr. David Recker, Vericel’s chief medical officer stated:

The results of the ixCELL-DCM study, which we believe is the largest randomized cell therapy trial to treat congestive heart failure completed to date, demonstrated a statistically significant and clinically meaningful reduction in cardiac events in patients who received treatment with ixmyelocel-T compared to placebo. We are very excited about these study results given the lack of treatment options for end-stage heart failure patients.

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