BioCentury
ARTICLE | Clinical News

CardioCell reports Phase IIa heart failure data

August 30, 2016 7:00 AM UTC

Data presented at the European Society of Cardiology meeting in Rome showed that a single intravenous administration of ischemic-tolerant mesenchymal stem cells ( itMSCs) from CardioCell LLC met the primary safety endpoint and several secondary efficacy endpoints in a single-blind Phase IIa trial to treat chronic heart failure (CHF) in patients with non-ischemic cardiomyopathy.

CardioCell CEO Sergey Sikora told BioCentury that IV itMSCs met the primary endpoint of the study by showing no differences versus placebo on multiple safety measures including all-cause mortality and all-cause hospitalizations. "The patient population in this trial consisted of stable, NYHA Class 2 and 3 CHF patients. Thus, few-to-no major events were expected in both groups," Sikora said. The trial enrolled 22 patients who were evaluated at baseline and 90 days after treatment. ...