In our initial application we successfully argued for the need to develop a novel human biomatrix model system to examine in vitro the neovascularization process in humans. The overall goal was and is to develop and commercialize the new human bioassay system employing defined Amgel matrices. This human biomatrix exhibits many advantages over existing models. Amgel's unique physiologic properties allowed one to generate matrix environment with defined or controllable bioactivity. Phase I work definitely established that the 3-D Amgel system simulate discrete human vascular cell functions in vitro. We propose two extended tasks in this second Phase to fully accomplish our R&D objectives. They are: 1. To establish efficient protocols for Amgel production, biomatrix analysis and formulation at commercial scale using advanced automated technologies; and 2. To complete the development of the defined human biomatrix systems and validate the practical applications of final products for vascular biology research As evident from our progress, this marketable human biomatrix will be useful for: I) evaluating the mitogenic, motogenic and differentiation responses of human cell/tissue derived factors; 2) examining the potential regulators of early to late neovascularization events; and 3) rapid screening of pro- and anti-angiogenic agents. New artificial vessel system also allows one to examine cell-matrix interactions under both physiologic and pathologic conditions. Thus, there is significant potential for the commercialization of our human biomatrix system for use in biomedical and pharmaceutical research.
No acceptable commercial bioassay system for angiogenesis, vasculogenesis currently exists which utilizes a defined human biomatrix. We will develop, optimize and evaluate both reusable and disposable bioassay systems. Sale of proprietary Amgel and pre-packed assay systems would have a world-wide market, both as a research and diagnoostic tool, in the hundreds of thousands of dollars in first 2-3 years. This will impact the fields of wound healing, tissue engineering and vascular diseases.
