After 12 months of follow-up, the composite primary endpoint was seen in 38 percent of patients given the stem cell therapy, a significantly lower proportion than the 49 percent of patients experiencing the primary endpoint in the control group.
“Percutaneous intramyocardial delivery of this enhanced bone marrow product resulted in a significant reduction in cardiovascular clinical events compared to placebo,” Henry said. “This is an exciting result and pushes us to do a larger trial to confirm this reduction in events.”
Ad Statistics
Times Displayed: 112999
Times Visited: 6736 MIT labs, experts in Multi-Vendor component level repair of: MRI Coils, RF amplifiers, Gradient Amplifiers Contrast Media Injectors. System repairs, sub-assembly repairs, component level repairs, refurbish/calibrate. info@mitlabsusa.com/+1 (305) 470-8013
Secondary endpoints included each of the endpoints within the composite primary endpoint, along with the total number of clinical events and assessments of patients’ heart function and quality of life. The stem cell therapy was associated with beneficial results for most of these secondary outcomes, although the trial was not large enough to show statistical significance for these secondary findings.
Among patients given stem cell therapy, 3.4 percent died and 37.9 percent were hospitalized with cardiovascular problems, as compared to 13.7 percent and 49.0 percent, respectively, in the placebo group. Patients given stem cell therapy also had, on average, a longer amount of time until their first adverse event. Other measures of heart function and quality of life, including a walking endurance test and a measurement of the amount of blood pumped out of the left ventricle with each contraction, also suggested improvements in the group receiving ixmyelocel-T.
The trial builds upon lessons learned from previous smaller-scale stem cell studies, which have mostly shown modest improvements in outcomes for heart failure. Past trials with ixmyelocel-T have shown better results in patients with ischemic cardiomyopathy than in those with nonischemic cardiomyopathy, a form of heart disease that is caused by heart muscle disorders, so the new trial enrolled only patients with ischemic cardiomyopathy. In addition, previous studies have shown greater success with procedures in which the stem cells are injected percutaneously via the groin compared with open-heart surgery, so the new trial used a percutaneous approach.
A key limitation of the new trial is its modest size. Henry said the next step is to expand the investigation of percutaneous, intramyocardial ixmyelocel-T treatment in a larger sample of heart failure patients with ischemic cardiomyopathy.
The study was funded by Vericel, a company for which Henry serves as a steering committee member.
