ANN ARBOR, Mich., Feb. 1 (UPI) -- Aastrom said Thursday the U.S. Food and Drug Administration granted orphan-drug status to its tissue-repair cells for cardiomyopathy.
Aastrom hopes its proprietary tissue-repair cells, or TRCs, can be used to induce heart-tissue regeneration in patients suffering from dilated cardiomyopathy, a severe chronic disease of the heart.
"Achieving this milestone is the first step in building the foundation for our clinical program in cardiac regeneration," said George Dunbar, Aastrom's president and chief executive officer.
"The next anticipated milestone for our cardiac program is to initiate a clinical trial that treats patients with dilated cardiomyopathy," Dunbar added.
Aastrom's TRCs contain stem and progenitor cells derived from the patient's own bone marrow. The company said that, if TRCs prove effective, they could eliminate or delay the need for a heart transplant in dilated cardiomyopathy patients.
