Aastrom Biosciences Inc has received a grant from the National Institute of Diabetes and Digestive and Kidney Diseases, providing research funding of up to $443,000 over a two-year period. This Small Business Innovation Research Phase I grant from the National Institutes of Health (NIH) will support studies to further optimize the production of Aastrom's Tissue Repair Cells (TRCs) for the clinical generation of normal human tissue.

"This grant validates our strategic industry position and our capability to develop cell products that are able to generate normal human tissues in patients," said R. Douglas Armstrong, President, Chief Executive Officer and Chairman of Aastrom. "In addition to other cell types, Aastrom's TRCs contain high numbers of mesenchymal cells that we believe are capable of maturing to form tissues such as bone, cartilage and vascular tissue. TRCs are the basis for our focus on the bone and vascular segments of the cell therapy marketplace. Through our unique, patented technology, we can enable an effective approach that provides for the use of TRCs in the clinic. This NIH grant supports the expansion of Aastrom's development program that should enhance our TRC process to address growing medical needs."

Stem cells and other types of cells found in bone marrow are capable of generating many types of human tissues and are therefore useful in a variety of potential medical treatments. Aastrom has patented technology for the production of these different types of cells. This grant will fund studies to further develop and refine Aastrom's cell production devices, as well as the process used to produce these important cells.

Aastrom's technology provides a novel approach for the production of clinical quantities of mesenchymal cells including a fixed short-term (12-day) production cycle utilizing the AastromReplicell System (ARS), the only automated, Good Manufacturing Practices (GMP) compliant cell production system. In addition, Aastrom's approach allows the inclusion of other non-mesenchymal cell types that may aid normal tissue repair, as well as the inclusion of mesenchymal cells at multiple stages of maturation or development, as opposed to the use of a single stage of cell, that may be less effective.

TRCs are Aastrom's proprietary mixture of stem and progenitor cells, including mesenchymal cells, which can form bone, cartilage and other tissues, produced from a small amount of bone marrow using the ARS. A typical TRC product contains more than a 70-fold increase in bone-forming cell types. TRCs have been safely used in over 150 patients to generate normal bone marrow, as well as bone, blood and immune system cells. While there are many research approaches to growing mesenchymal cells, Aastrom believes that its technology is unique for a growing number of clinical applications.