Federally Registered Human Embryonic Stem Cell Center

描述（由申请人提供）： 人类胚胎干细胞（hES）虽然是研究和临床应用的强大工具，但可用性有限。关于使用hES细胞和限制联邦资助资格的现行法规使得合格细胞系的分布和新研究者的教育尽可能广泛成为首要问题。UCSF hES分配和培训计划是为了应对这些限制而启动的，以向世界各地学术机构的研究人员提供HSF-6（UCO 6）和HSF-1（UCO 1），这两种hES细胞系是在UCSF的NIH人类胚胎干细胞登记处获得的。最初计划的目标是分发来自UCSF的两种hES细胞系，HSF-6和HSF-1，并继续和扩大访问研究人员的培训计划。已经建立了一个分配程序，在该程序下，细胞大量扩增，并检测无菌性、hES细胞特性和分化潜力。已经启动了一项针对合格技术人员的培训计划，为接受实验室提供在其实验室成功建立hES培养所需的专业知识。最后，UCSF可用的hES细胞系已适应药物非临床研究质量管理规范。这项建议延伸和扩大了2002年5月该方案开始的努力。该分配计划将扩大到包括有用的遗传修饰的hES系、GFP标记的细胞和来自HSF-6系的Tet-inducible细胞。方案书和培训手册将扩展到包含我们实验室中使用的hES细胞增殖和表征的全套方案。为了帮助向世界各地的学术机构分发，该计划的网站将扩大，为用户和感兴趣的个人提供有关细胞系和hES研究的信息。此外，还将公布这些议定书。最后，HSF-6和HSF-1细胞系将被转移到UCSF GMP设施，以创建一个临床使用的认证细胞库。因此，该计划的扩展将支持hES细胞在研究和临床领域的应用。

DESCRIPTION (provided by applicant): Human embryonic stem (hES) cells, although powerful tools for research and clinical uses, are limited in availability. Current regulations regarding the use of hES cells and limiting eligibility for federal funding, makes the distribution of the eligible lines and education of new investigators as widely as possible, of primary importance. The UCSF hES distribution and training programs were initiated in response to these limitations to supply investigators in academic institutions throughout the world with HSF-6 (UCO6) and HSF-1 (UCO1), the two hES cell lines derived at UCSF on The NIH Registry of Human Embryonic Stem Cells. The goal of the original program was to distribute the two hES cell lines derived at UCSF, HSF-6 and HSF-1, and to continue and expand the training program for visiting investigators. A distribution program has been established, under which the cells are expanded in large lots, and tested for sterility, hES cell characteristics, and differentiation potential. A training program has been initiated for qualified technical staff to provide recipient labs with the expertise necessary to successfully establish hES cultures in their own lab. Finally, the hES cell lines available at UCSF, have been adapted to good laboratory practices. This proposal extends and expands the efforts begun by this program in May of 2002. The distribution program will be expanded to include useful genetically modified hES lines, GFP-marked cells and Tet-inducible cells derived from the HSF-6 line. The protocol book and training manual will be expanded to contain the full set of protocols for hES cell propagation and characterization utilized in our lab. To assist in the distribution to academic facilities throughout the world, the program website will be expanded the provide users and interested individuals with information about the cell lines and hES research. In addition, these protocols will be published. Finally, the HSF-6 and HSF-1 lines will be transferred to the UCSF GMP facility to create a bank of certified cells for clinical use. Thus, the extension of this program will support the utility of hES cells for both the research and clinical communities.