A Defined Biomatrix Model for Human Vascular Studies

描述（由申请人提供）：在我们的初步申请，我们成功地 认为需要开发一种新的人类生物基质模型系统， 在体外研究人类的新血管形成过程。总体目标是， 开发和商业化新的人体生物测定系统， Amgel矩阵。这种人类生物基质与现有的生物基质相比具有许多优点， 模型Amgel独特的生理特性使人们能够生成基质 具有确定的或可控的生物活性的环境。第一阶段肯定有效 建立了三维Amgel系统模拟离散的人血管细胞 在体外发挥作用。我们在第二阶段提出两项扩展任务， 实现我们的研发目标。它们是： 1.为了建立Amgel生产的有效方案，生物基质分析 以及使用先进的自动化技术进行商业规模的配制;以及 2.完成定义的人体生物基质系统的开发， 验证血管生物学最终产品的实际应用 研究 从我们的进展中可以明显看出，这种可销售的人类生物基质将是有用的。 用于：I）评估以下细胞的促有丝分裂、促运动和分化反应： 人细胞/组织衍生因子; 2）检查 早期至晚期新生血管形成事件;和3）快速筛查促新生血管形成和 抗血管生成剂。新的人造血管系统也允许人们检查 在生理和病理条件下的细胞-基质相互作用。 因此，我们人类的商业化潜力巨大。 用于生物医学和制药研究的生物基质系统。 拟定商业应用： 目前还没有可接受的用于血管生成、血管发生的商业生物测定系统，其利用了定义的人类生物基质。我们将开发，优化和评估可重复使用和一次性生物测定系统。专利的Amgel和预包装的测定系统的销售将具有世界范围的市场，作为研究和诊断工具，在前2-3年内价值数十万美元。这将影响伤口愈合、组织工程和血管疾病领域。

DESCRIPTION (provided by applicant): 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. PROPOSED COMMERCIAL APPLICATION: 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.