Aastrom Biosciences has begun patient enrollment in the ixCELL-DCM Phase 2b trial of Ixmyelocel-T in the US.
Randomized, double-blind study will assess ixmyelocel-T’s efficacy and safety in treating patients with advanced heart failure due to ischemic dilated cardiomyopathy.
Aastrom Biosciences acting chief medical officer 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."
Placebo-controlled study is scheduled to enrol 108 patients and ixmyelocel-T will be administered by means of catheter-based injections.
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.
Aastrom president and chief executive officer Nick Colangelo said, "We have increased the number of sites participating in this study which will help us build momentum in patient enrollment and complete the trial on schedule."