Open Competition 2 - Biotechnology

Technology for Room-Temperature Storage of Living Human Cells and Organs

Sponsor: Stratatech Corporation

• Project Performance Period: 7/1/2003 - 6/30/2006
• Total project (est.): $2,646,687.00
• Requested ATP funds: $1,999,608.00

Rapid advances in many areas of biological science and technology are fueling explosive growth in the tissue engineering industry, which is marketing or developing dozens of products such as skin substitutes. However, broad acceptance of these products and industry profitability are hindered by the lack of efficient, effective preservation methods. Typically, tissue-engineered products take weeks or months to produce but must be used within hours or days, resulting in frequent inventory losses and high operating costs. Traditional cryogenic preservation techniques induce tissue damage and require specialized handling methods. Stratatech Corp. (Madison, WI) plans a three-year project to develop and demonstrate technologies for room-temperature preservation and shipping of living cells, tissues, and tissue-engineered products. The approach involves a rapid, ice-free freezing process called vitrification, followed by drying. The company plans to introduce genes into mammalian cells to enable them to synthesize, or absorb from culture media, sugars and proteins to enhance intracellular vitrification. The company also will implement several recent advances in cryopreservation and freeze-drying solution development. The technical risk is high because it is not clear whether cells and tissues can be produced with all the desired properties, including retention of viability, structure, and function. The company first will attempt to to preserve in the dry state a proprietary skin cell line as well as human adult mesenchymal stem cells, which can mature into cartilage and bone cells and already are used in developing therapeutic products. Stratatech then will demonstrate vitrification and drying of a living human skin equivalent. ATP funding is needed because of the high technical risk and the current volatility of tissue engineering markets; the support will accelerate development of the technology by 6 to 10 years. If successful, the project will extend the shelf life of tissue-engineered products, reduce prices and inventory losses, enable storage at the point of care and thereby expand applications and extend market opportunities to segments such as chronic wound treatment. The project also could reduce medical costs and benefit the more than 2 million Americans with unhealable diabetic foot ulcers, burns, and large skin wounds. Other applications for the engineered human mesenchymal stem cells could include treatments for heart attack or diabetes.

For project information:

Paul Conrad, (608) 441-2750
pconrad@stratatechcorp.com

ATP Project Manager

Douglas Bischoff, (301) 975-8597
douglas.bischoff@nist.gov