Aastrom Biosciences Inc. (NSDQ:ASTMD) 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 press release.
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.
Aastrom’s technology involves producing cardiac-repair cells from a patient’s own bone marrow stem cells and injecting them into the wall of the patient’s left ventricle. The study’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 study, 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.
Last week, the company avoided de-listing from the NASDAQ exchange, after regaining compliance with the exchange’s $1 minimum-share-price requirement.
Plymouth, Mass.-based Harvest Technologies Corp. is also in the hunt after stem cell-based treatments for CLI and cardiac conditions. Last December Harvest released positive results from a clinical trial in India of its technique to use concentrated autologous bone marrow cells to treat patients with non-reconstructable CLI. And in Octopber 2009 the company got the green light from the Food & Drug Administration to conduct a 42-patient trial of its technique to use stem cells to treat patients undergoing coronary artery bypass grafts.