Center of Excellence in Gene Therapy(PROGRAM PROJECT)

描述(由申请人提供) 此计划项目拨款申请(PPG)是 我们最初针对RFA HL-00-008提交的提案 为圣伊丽莎白医院的基因治疗卓越计划(PEGT)提供资金 医疗中心(SEMC)/塔夫茨大学医学院(TUSM) 来自克利夫兰诊所外科的合作，以及 生物统计中心，乔治华盛顿大学，罗克维尔，马里兰州。这个 PPG由三个临床项目和两个临床前项目组成， 由四核支持。杰弗里·M·伊斯纳博士，首席调查员(PI) 全面负责PPG，将担任以下项目总监 (临床)项目1，“血管内皮生长因子基因转移治疗糖尿病神经病变”。Dr。 道格拉斯·洛索多将指导(临床)项目2，“将血管内皮生长因子基因转移到 预防冠状动脉再狭窄。“(临床)项目3，”血管内皮生长因子基因。 促进进展性心力衰竭患者血管生成的基因转移 由克利夫兰诊所外科主任帕特里克·麦卡锡博士执导 考夫曼心力衰竭中心。肯·沃尔什博士将担任该项目 (临床前)项目4“心力衰竭的分子研究”的主任。 麻原隆幸博士将执导(临床前)项目5“内皮细胞 祖细胞基因转移“。 PPG的研究生产力和功能能力将得到提高 四个核心。核心A，即质粒核心，将提供临床级别的质粒 DNA载体，并将由沃尔什博士监督。核心B，行政部门 由洛索多博士领导的CORE将提供关键的行政援助。 洛索尔多和沃尔什博士还将指导核心C，即培训核心。核心D， 数据管理核心，由Kathryn Hirst博士研究助理指导 乔治华盛顿大学生物统计中心教授将 协助数据管理和分析，并将确保遵守 所有适当的监管机构。 本PPG中概述的研究和组织旨在提供高质量的 高质量和可信的基因临床和临床前研究 这将代表着对科学和技术两方面的有意义的贡献 社区和大众。

DESCRIPTION (provided by the applicant) This Program Project Grant Application (PPG) is a revised version of a Proposal which we initially submitted in response to RFA HL-00-008 to seek funding for a Program of Excellence in Gene Therapy (PEGT) at St. Elizabeth's Medical Center (SEMC)/Tufts University School of Medicine (TUSM) with collaboration from the Cleveland Clinic Department of Surgery, and the Biostatistics Center, George Washington University, Rockville, Maryland. The PPG consists of three Clinical Projects and two Pre-clinical Projects, supported by four Cores. Dr. Jeffrey M. Isner, Principal Investigator (PI) with overall responsibility for the PPG, will serve as Project Director for (clinical) Project 1, "VEGF Gene Transfer for Diabetic Neuropathy." Dr. Douglas Losordo will direct (clinical) Project 2, "VEGF Gene Transfer to Prevent Coronary Artery Restenosis." (Clinical) Project 3, "VEGF Gene Transfer to Promote Angiogenesis in Patients with Advance Heart Failure," will be directed by Dr. Patrick McCarthy, Surgical Director of the Cleveland Clinic Kaufman Center for Heart Failure. Ken Walsh, Ph.D. will serve as Project Director for (pre-clinical) Project 4, " Molecular Studies of Heart Failure." Dr. Takayuki Asahara will direct (pre-clinical) Project 5, "Endothelial Progenitor Cell Gene Transfer." The research productivity and functional capacity of the PPG will be enhanced by four Cores. Core A, the Plasmid Core, will provide clinical grade plasmid DNA vector, and will be supervised by Dr. Walsh. Core B, the Administrative Core, directed by Dr. Losordo, will supply critical administrative assistance. Drs. Losordo and Walsh will also direct Core C, the Training Core. Core D, the Data Management Core, directed by Kathryn Hirst, Ph.D. Research Associate Professor of the Biostatistics Center, George Washington University will assist with data management and analysis, and will also ensure compliance with all appropriate regulatory bodies. The studies and organization outlined in this PPG are intended to provide high quality and credible clinical as well as pre-clinical research studies of gene transfer that will represent meaningful contributions to both the scientific community and lay public.