Aastrom Biosciences has treated first patients in ixCELL-DCM Phase 2b trial of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).
The trial is designed to assess the safety and efficacy profile of ixmyelocel-T administered via catheter-based injections against placebo.
Aastrom Biosciences president and chief executive officer Nick Colangelo said, "We are very enthusiastic about evaluating the therapeutic potential of ixmyelocel-T to treat patients with DCM, and grateful to our study coordinators and investigators for their progress in moving this important clinical program forward."
The randomized, double-blind, placebo-controlled study is expected to enroll 108 patients at approximately 30 sites in the US.
The average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure over 12 months is the primary endpoint.