Aastrom Biosciences Inc has received a Small Business Innovation Research Phase I grant from the National Institutes of Health (NIH) entitled "Clinical-Scale Production of Osteoprogenitor Cells". The grant will support investigations to expand the Company's development of effective stem cell-based approaches for the regeneration of bone in patients requiring a bone graft treatment. Bone grafting is required annually in over one million people in the United States and Europe, for orthopedic procedures such as fusion of spine vertebrae, repair of major leg fractures, and other bone repair applications.
The six-month study, funded at $110,062 by the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases, seeks to further optimize Aastrom's proprietary technology for producing its line of Tissue Repair Cells (TRCs), which are mixtures of stem and other cells produced from a small starting sample of the patient's own bone marrow. The Company has previously demonstrated that its TRCs contain a large number of bone-forming stem cells, at levels equivalent to that found in approximately a liter or more of bone marrow. The new studies will explore ways to further increase the types of cells that may provide a more potent treatment, and ways to simplify the production process towards a more cost-effective endpoint.
Aastrom is seeking to replace the current standard approach for bone grafting that involves an invasive collection of bone and tissue from the patient's hip, which is then used for the graft application (called "autograft"). The associated acute and chronic pain, as well as limited amounts of source material from this autologous graft collection procedure, has created a need for an alternative approach for bone repair. The Company believes that the large number of bone-forming cells in its TRC product, when combined with a carrier matrix may provide an effective alternative to the traditional autograft procedure, offering more flexible options for orthopedic surgeons and their patients. This same technology approach may also be extended in the future to the generation of cartilage and vascular tissue.
This is the third NIH grant awarded to the Company in the last quarter providing support for its TRCs and its industry-unique cell production platform, the AastromReplicell System. The announcement of these grants provides important recognition of Aastrom's strategic position in the bone regeneration field. These third party validations were enhanced when the Company announced a strategic alliance with one of the largest participants in the bone graft field, the Musculoskeletal Transplant Foundation (MTF) in early June 2003. This alliance combines Aastrom's TRCs with MTF's allograft matrices to coordinate a development path to bring these products through U.S. clinical trials and into the marketplace.
Aastrom also previously announced an additional collaboration with Mathys Medical, Ltd., a leader in the development of synthetic bone matrix products located in Switzerland, and Bergmannsheil University Clinic, a leading orthopedic treatment center in Germany, to begin an European clinical trial using the Company's TRCs for bone grafting in the repair of tibial non-union fractures. The Company has also submitted its lead bone graft trial plan to the U.S. Food and Drug Administration (FDA), and is currently in discussion with the FDA to move forward with this clinical track.
The studies supported by this grant will be completed at Aastrom and at Case Western Reserve University, one of the Company's collaborators in the analysis of its bone-forming technology. Following completion of the specific objectives in this Phase I study, the Company intends to submit a follow-on Phase II proposal for additional grant funding.