Vericel (VCEL) Will Present ixCELL‑DCM Trial Data at AHA Scientific Sessions 2016
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Vericel Corporation (Nasdaq: VCEL) announced the acceptance of an abstract for presentation at the American Heart Association’s Scientific Sessions 2016 entitled “Reduction in Ventricular Arrhythmias with Ixmyelocel-T: Results from the ixCELL‑DCM Trial”. The poster will be presented by Timothy Henry, M.D., director of cardiology at Cedars-Sinai Heart Institute, principal investigator of the study, and co-author of the poster, on Monday, November 14, 2016 at 2:00pm EDT. The measurement of ventricular arrhythmia episodes resulting in appropriate shocks or ATP (anti-tachycardia pacing) was a pre-specified secondary endpoint of the recently completed ixCELL-DCM trial.
|AHA Poster Session Information|
|Session Title:||Treatments, Trials, and Unique Approaches to Heart Failure Management|
|Poster Title:||Reduction in Ventricular Arrhythmias with Ixmyelocel-T: Results from the ixCELL-DCM Trial|
|Date:||Monday, November 14, 2016, 2:00pm to 3:15pm|
|Location:||Science and Technology Hall, Clinical Science Section|
The poster will be available online at the time of the presentation at http://aha.scientificposters.com.
About Ixmyelocel-TIxmyelocel-T is an autologous, expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's proprietary, highly automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. Ixmyelocel-T has been designated as an orphan drug by the U.S Food and Drug Administration and is intended for use in the treatment of Dilated Cardiomyopathy Dilated cardiomyopathy (DCM).
About the ixCELL-DCM Clinical Trial
The ixCELL-DCM clinical trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study designed to assess the efficacy, safety, and tolerability of ixmyelocel-T compared to placebo when administered via transendocardial catheter-based injections to patients with end-stage heart failure due to ischemic DCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit. The primary endpoint of the ixCELL-DCM clinical trial study was a composite of the number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient and emergency department visits to treat acute decompensated heart failure over the 12 months following administration of ixmyelocel-T compared to placebo. In March 2016, Vericel announced that the trial met its primary endpoint of reduction in clinical events of the composite endpoint, and that there were fewer adverse events and serious adverse events in patients treated with ixmyelocel-T compared with placebo.
About Dilated Cardiomyopathy and Ventricular Arrhythmias
Dilated cardiomyopathy (DCM), a progressive disease of the heart, is a leading cause of heart failure and heart transplantation. DCM is characterized by weakening of the heart muscle and enlargement of the heart chambers, leading to difficulty of the left ventricle to pump blood. Heart enlargement and poor function generally lead to progressive heart failure with further decline in the ability of the heart to pump blood efficiently throughout the body. Ventricular arrhythmias are a form of abnormal heart rhythm that originate in the ventricles of the heart and are common in patients with heart failure and cardiomyopathy. Previous studies have demonstrated an association between ventricular arrhythmias and an increased risk of sudden cardiac death in patients with left ventricular systolic dysfunction due to prior myocardial infarction.
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