Core--Data management

本计划项目资助申请（PPG）为圣伊丽莎白医学中心(SEMC)/塔夫茨大学医学院中心，乔治华盛顿大学，洛克维尔，马里兰州的基因治疗卓越计划（PEGT）寻求资金。PPG由三个临床项目和两个临床前项目组成，由四个核心支持。负责PPG的首席研究员Jeffrey M. Isner博士将担任（临床）项目1“VEGF基因转移治疗糖尿病神经病变”的项目主任。Douglas Losordo博士将指导（临床）项目2，“VEGF基因转移预防冠状动脉再狭窄”。（临床）项目3，“VEGF基因转移促进晚期心力衰竭患者血管生成，将由克利夫兰诊所考夫曼心力衰竭中心外科主任Patrick McCarthy博士指导。”Takayuki Asahara博士将指导（临床前）项目5，“内皮祖细胞基因转移”。四个核心将提高PPG的研究效率和功能能力，质粒核心将提供临床级质粒DNA载体，并将由行政协助监督。Losordo和Walsh博士也将指导培训核心。Core，数据管理核心，由Kathryn Hirst博士指导。乔治华盛顿大学生物统计中心的研究副教授将协助数据管理和分析，并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和可信的基因转移临床和临床前研究，这将为科学界和公众做出有意义的贡献。

This Program Project Grant application (PPG) seek funding for a Program of Excellence in Gene Therapy (PEGT) at St. Elizabeth's Medical Center (SEMC)/Tufts University School of Medicine Center, George Washington University, Rockville, MD. The PPG consists of three Clinical Projects and two Pre-clinical Projects, supported by four Cores. Dr. Jeffrey M. Isner, Principal Investigator (P.I.) 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 Restonosis." (Clinical) Project 3, "VEGF Gene Transfer to Promote Angiogenesis in Patients with Advanced Heart Failure, will be directed by Dr. Patrick McCarthy, Surgical Director of the Cleveland Clinic Kaufman Center for 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 enhanced by four Cores, the Plasmid Core, will provide clinical grade plasmid DNA vector, and will be supervised by administrative assistance. Drs, Losordo and Walsh will also direct the Training Core. Core, the Data Management Core, directed by Kathryn Hirst, PhD. 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.