SUPPORT DEVELOPMENT OF AN VITRO EXPERIMENTAL SYSTEM CAPABLE OF REPLICATING MAJOR

制药行业、化学公司、消费品制造商和许多其他行业需要准确可靠的工具来确定其产品的安全性或潜在毒性。多年来，人们一直依赖动物试验来提供这种毒性信息，但最近，出于科学和伦理方面的原因，这些试验的使用受到了质疑。美国国家科学院已经通过一份报告《21世纪的毒性测试：展望和战略》解决了这个问题，该报告展望了毒性测试依赖于三个基本组成部分的未来：高通量仪器、作为要筛选分子的目标组织的人体组织模型以及毒性途径的知识。RegeneMed将把其以前在全球范围内经过验证的人类3D全厚度皮肤组织SKIN2转换成高通量96孔板格式，并表征其特定于组织的功能和能力，以满足目前和预期的OECD刺激和腐蚀测试指南。第二阶段的合同活动将与RegeneMed正在进行的努力相配合，以使：1)OECD在2012年前接受用于几个急性终点的3D皮肤模型，2)将于2012年前提供用于验证的遗传毒性模型，以及3)皮肤机械模型，该模型将有助于解决2013年欧盟关于使用人体3D皮肤和肝脏的致癌、生殖和重复剂量毒性的最后期限。与公共卫生相关；全球研究、监管和立法团体正在达成共识，即传统的动物试验必须被更具预测性、成本更低、更快和更人道的方法所取代。人体3D组织培养提供人类临床前预测，并正在获得监管接受和常规使用。

The pharmaceutical industry, chemical companies, consumer product manufacturers and many other industries need accurate and reliable tools with which to determine the safety, or potential toxicity, of their products. For many years animal tests have been relied upon to provide this toxicity information, but recently the use of these tests has been called into question for both scientific and ethical reasons. The National Academies have addressed this issue with a report Toxicity Testing in the 21st Century: a Vision and a Strategy that envisions a future where toxicity testing relies on three basic components: high-throughput instrumentation, human tissue models as target tissues for the molecules to be screened, and knowledge of toxicity pathways¿. RegeneMed, will translate its former world-wide validated human 3D full-thickness skin tissue, Skin2 into high throughput 96-well plate formats and characterize its tissue-specific function and ability to meet current and expected OECD Test Guidelines for irritation and corrosion. Phase II contract activities would synergize with RegeneMed's ongoing efforts to have: 1) OECD accepted in 3D skin models for several acute endpoints by 2012, 2) a model for genotoxicity that will be available by 2012 for validation, and 3) mechanistic models in skin that will help address the 2013 EU deadlines for carcinogenicity, reproductive and repeat dose toxicity using human 3D skin and liver. RELEVANCE TO PUBLIC HEALTH; Worldwide research, regulatory and legislative groups are reaching a consensus that traditional animal testing must be replaced by more predictive, less costly, faster and more humane methods. Human 3D tissue cultures provide human preclinical prediction and are achieving regulatory acceptance and routine use.