Aastrom Biosciences Inc. has finished treating patients in a Phase 2 clinical trial of its cardiac-repair stem cells.
The milestone clears the way for Aastrom to report six-month interim results of the trial later this year, according to a statement from the company.
In the trial, Aastrom treated 40 patients suffering from dilated cardiomyopathy, a severe form of congestive heart failure in which the heart becomes weakened and enlarged and cannot pump blood efficiently.
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Aastrom’s technology involves producing cardiac-repair cells from a patient’s own bone marrow stem cells and then injecting them into the wall of a patient’s left ventricle, according to the statement. The trial’s primary objective is to determine whether it’s safe to use Aastrom’s technology to treat dilated cardiomyopathy patients, but the company will also measure the treatment’s efficacy.
Last month, the company announced plans to proceed with a separate Phase 3 clinical trial. In that trial, Aastrom will use a patient’s own bone marrow stem cells to treat critical limb ischemia, which results from decreased blood supply to a limb and is often the endpoint of peripheral arterial disease.
