A Defined Biomatrix Model for Human Vascular Studies

描述(申请人提供)：在我们最初的申请中，我们成功地 认为有必要开发一种新的人类生物矩阵模型系统来研究 在体外，人类的新生血管过程。总体目标过去是，现在也是 利用Defined开发和商业化新的人体生物检测系统 安格尔矩阵。这种人类生物矩阵比现有的生物矩阵显示出许多优势 模特们。AmGel独特的生理特性使人能够产生基质 具有明确或可控生物活性的环境。第一阶段的工作肯定是 建立了3-D AmGel系统模拟离散的人类血管细胞 在体外发挥作用。我们在第二阶段提出了两项扩展任务，以充分 完成我们的研发目标。它们是： 1.建立高效的凝胶生产工艺，生物基质分析 并使用先进的自动化技术进行商业规模的配方；以及 2.完成已定义的人类生物矩阵系统的开发和 验证最终产品在血管生物学中的实际应用 研究 从我们的进步可以看出，这种有市场的人类生物矩阵将是有用的 用于：i)评估细胞的有丝分裂、运动和分化反应 人类细胞/组织衍生因子；2)检测潜在的调节因子 早期到晚期的新生血管事件；以及3)快速筛查前和 抗血管生成药物。新的人造血管系统也允许人们检查 生理和病理条件下的细胞-基质相互作用。 因此，我们的人类有巨大的商业化潜力 用于生物医学和制药研究的生物基质系统。 建议的商业应用： 目前还没有可接受的用于血管生成的商业生物测定系统，目前存在利用定义的人类生物基质的血管生成。我们将开发、优化和评估可重复使用和一次性生物检测系统。在最初的2-3年内，销售专有的AMGel和预包装的分析系统将拥有一个全球市场，无论是作为研究和诊断工具，都将达到数十万美元。这将对伤口愈合、组织工程和血管疾病领域产生影响。

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.