Aastrom Biosciences has enrolled the first patients in the ixCELL-DCM Phase IIb clinical trial of ixmyelocel-T in the US.
The Phase IIb study will evaluate the efficacy and safety of ixmyelocel-T in treating patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).
Aastrom Biosciences acting chief medical officer Dr David Recker said; "Enrolling the first patients in the ixCELL-DCM trial is an important milestone in our effort to bring this potential new treatment for advanced heart failure to thousands of people who might benefit from it."
The randomised, double-blind, placebo-controlled Phase IIb study is expected to enrol 108 patients at 30 sites in the US.
Ixmyelocel-T will be administered through catheter-based injections to patients with advanced heart failure due to ischemic DCM.
The average number of events per patient, such as all-cause mortality, all-cause hospitalisations or unplanned hospital visits to treat worsening heart failure, will be the primary endpoint.
The study patients will undergo follow up for 12 months.
Aastrom president and chief executive officer Nick Colangelo said the clinical programme is focused on the development of ixmyelocel-T for the treatment of dilated cardiomyopathy and other rare disease indications.
"We have increased the number of sites participating in this study, which will help us build momentum in patient enrolment and complete the trial on schedule," Colangelo said.
