ANN ARBOR — Aastrom Biosciences Inc. (Nasdaq:ASTM), the developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that the first patients have been enrolled in the ixCELL-DCM clinical trial.
This Phase 2b study is currently underway in the United States to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).
“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,” said David Recker, acting chief medical officer at Aastrom Biosciences.
The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled phase 2b study with a planned enrollment of 108 patients at approximately 30 sites in the U.S. In the study, ixmyelocel-T will be administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial will be the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure. Patients will be followed for a total of 12 months.
“We recently refocused our clinical program on the development of ixmyelocel-T for the treatment of dilated cardiomyopathy and other rare disease indications and are delighted to enroll our first patients in the ixCELL-DCM study,” said Nick Colangelo, president and chief executive officer at Aastrom Biosciences. “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.”
For more information on ischemic DCM and ixmyelocel-T, visit