Open Competition 2 - Biotechnology

Neocartilage Osteochondral Allograft Development

Sponsor: ISTO Technologies

• Project Performance Period: 10/1/2001 - 9/30/2004
• Total project (est.): $3,180,000.00
• Requested ATP funds: $2,000,000.00

Articular cartilage -- the resilient tissue that cushions joints such as the knee -- cannot repair itself after injury. Cartilage defects and injuries often lead to arthritis, which causes severe pain and functional disability and imposes substantial health care costs and productivity losses. The only surgical treatment is total joint reconstruction, which is costly, limited to 10 to 15 years of useful life, and not recommended for young patients. ISTO Technologies plans to develop and characterize a neocartilage graft -- a cartilage-like tissue -- that eventually could be used to resurface or replace joint articular cartilage. ISTO already has developed methods of producing neocartilage by culturing cells derived from mammalian cartilage, and has used it to repair lesions in animals. In the three-year project, the company will enhance the technology by developing means of establishing a strong bond between the neocartilage and a bone platform, and attaining normal cartilage-like structure with sufficient biomechanical strength. Once the cultured graft material exhibits adequate structural, biomechanical, and biochemical properties, its therapeutic capability will be evaluated in studies using sheep. The company also will examine why neocartilage apparently is not rejected by a recipient's immune system. Researchers from the Massachusetts Institute of Technology Center for Biomechanical Engineering (Cambridge, Mass.), the University of Wisconsin School of Veterinary Medicine (Madison, Wisc.), and Barnes-Jewish Hospital and the Washington University School of Medicine (St. Louis, Mo.) will characterize the neocartilage and grafts, oversee the animal studies after graft implantation, and perform the immune system studies. ATP funding will accelerate the research by as much as a year and is needed because orthopedic companies, although interested in the technology, have not supported the research at this early stage. It is hoped that the data from the ATP project can be used to support a proposal for human clinical studies. If successfully developed and commercialized, the new technology could greatly improve quality of life for the more than 33 million arthritis sufferers in the United States and the millions more who have cartilage lesions. This advance could reduce the medical and lost productivity costs associated with arthritis, estimated at $64 billion annually. In addition, the immune system studies could lead to ways to reduce the common and costly problem of rejection of transplanted organs.

For project information:

Edward L. Bayham, (314) 995-6049
ebayham@istotech.com

ATP Project Manager

Thomas Wiggins, (301) 975-5416
thomas.wiggins@nist.gov