Significant reduction in primary efficacy end point with ixmyelocel-T therapy
MONDAY, April 4, 2016 (HealthDay News) — Ixmyelocel-T, an expanded multicellular therapy produced from a patient’s own bone marrow, is effective for patients with heart failure and reduced ejection fraction, according to a study published online April 4 in The Lancet. The research is being published to coincide with the annual meeting of the American College of Cardiology, held from April 2 to 4 in Chicago.
For the study, Amit N. Patel, M.D., from the University of Utah Health Care in Salt Lake City, and colleagues enrolled patients with symptomatic heart failure due to ischemic dilated cardiomyopathy and a left ventricular ejection fraction of 35 percent or less. Participants were randomized to receive ixmyelocel-T (60 patients) or placebo (66 patients) at the time of bone marrow aspiration (58 and 51 patients, respectively, were included in the per-protocol primary efficacy analysis).
The researchers found that the primary efficacy end point (composite of all-cause death, cardiovascular admission to hospital, and unplanned clinic visits to treat acute decompensated heart failure) was seen in 49 percent of patients in the placebo group and 38 percent of patients in the ixmyelocel-T group (risk ratio, 0.63; P = 0.0344). Serious adverse events occurred in 75 and 53 percent of the placebo group and ixmyelocel-T group, respectively (P = 0.0197).
“The effect of an autologous biological agent on the clinical outcomes of ischemic dilated cardiomyopathy has great potential for the future of congestive heart failure management,” the authors write.
Several authors disclosed financial ties to Vericel Corporation, which funded the study.
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