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Aastrom Biosciences, Inc.
ASTM, the leading 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).
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.
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