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news.Vericel said its ixmyelocel-T drug reduced death, hospitalizations and emergency visits in patients who are at risk of a heart failure in a phase 2b clinical trial.
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The drug was studied in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM), a condition in which the heart becomes enlarged and cannot pump blood efficiently.
A total of 114 patients were treated in the phase 2b ixCELL-DCM clinical trial at 28 sites in the US.
The study was designed to evaluate the efficacy, safety and tolerability of ixmyelocel-T compared to placebo when administered through transendocardial catheter-based injections to subjects with end-stage heart failure because of ischemic DCM, who have no reasonable revascularization options either surgical or percutaneous interventional.
Vericel chief medical officer David Recker said: "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."
Ixmyelocel-T, which has an orphan drug status in the US, is an expanded multicellular therapy manufactured from the patient’s own bone marrow using Vericel’s cell-processing system.
Vericel said the process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which produce anti-inflammatory and pro-angiogenic factors believed to be crucial for repair of damaged tissue.