Aastrom secures US patent for autologous cell therapy product

Aastrom Biosciences, Inc., a leading developer of expanded autologous cellular therapies for severe, chronic cardiovascular diseases, today announced that it has been granted a U.S. patent which provides composition of matter protection for its investigational expanded autologous cell therapy product.

The issued patent, entitled Mixed Cell Populations for Tissue Repair and Separation Technique for Cell Processing, broadly covers "an isolated cell composition for tissue repair comprising a mixed population of cells of hematopoietic, mesenchymal and endothelial lineage." The company's patented single-pass perfusion technology enables the selective expansion of certain cell populations which have been shown to promote wound healing, new blood vessel formation and tissue restoration and address the underlying inflammation associated with CLI.  

"This is a fundamental patent for Aastrom which expands our intellectual property estate and supports the basis for a proprietary cellular therapy product derived from our technology," said Tim Mayleben, president and CEO of Aastrom Biosciences. "The patent establishes the novelty of our cell populations which we believe produce a greater combined therapeutic benefit than purified cell populations or freshly isolated bone marrow cells. We are pleased that the U.S. patent office now recognizes this cell mixture to be unique to Aastrom." 

Aastrom's expanded autologous therapy is now in clinical trials for the treatment of critical limb ischemia (CLI) and dilated cardiomyopathy (DCM). In October 2010, the company announced that its planned Phase 3 clinical program in CLI received Fast Track designation by the U.S. Food and Drug Administration. The company also submitted documents to the FDA in support of special protocol assessments for the program.

Aastrom now has 26 U.S. and 36 foreign patents covering the composition, production and use of mixed-cell products.