IGF::OT::IGF - GTRP Coordinating Center services. CAN 8470187; FY13; $803,731

IGF::OT::IGF - GTRP 协调中心服务。

• 批准号: 8755774
• 负责人: SONIA DUA
• 金额: $ 80.37万
• 依托单位: SOCIAL AND SCIENTIFIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8755774
• 关键词: Area; Basic Science; Clinical; Clinical Trials; Dependovirus; Funding; Heart Diseases; Hematological Disease; Laboratories; Logistics; Lung diseases; National Heart, Lung, and Blood Institute; Pharmacology and Toxicology; Production; Research Personnel; Resources; Services; Site Visit; Subfamily lentivirinae; Translations; clinical application; gene therapy; gene therapy clinical trial; meetings; pre-clinical; programs; symposium; vector

The Clinical Coordinating Center (CCC) for the existing Gene Therapy Resource Program (GTRP) facilitates the translation of basic research in gene therapy to clinical application in the areas of heart, lung, and blood diseases. The GTRP renewal allows the program to continue providing resources in the areas of preclinical and clinical-grade vector production in accordance with Good Manufacturing Practices (GMP), and in the conduct of pharmacology/toxicology studies. In addition, the GTRP will continue to provide funds and regulatory assistance to investigators wishing to conduct gene therapy clinical trials. The GTRP consist of a clinical coordinating center that oversees and coordinates the logistics of the core laboratories and provides regulatory assistance for clinical trials; a preclinical-grade vector production core laboratory; a clinical-grade vector production core laboratory for adeno-associated virus (AAV); a clinical-grade vector production core laboratory for lentivirus; and a pharmacology/toxicology core laboratory.

现有基因治疗资源计划（GTRP）的临床协调中心（CCC）促进了基因治疗基础研究在心脏，肺和血液疾病领域的临床应用。GTRP的更新使该计划能够继续根据良好生产规范（GMP）在临床前和临床级载体生产领域提供资源，并进行药理学/毒理学研究。此外，GTRP将继续为希望进行基因治疗临床试验的研究人员提供资金和监管援助。GTRP包括一个临床协调中心，负责监督和协调核心实验室的后勤工作，并为临床试验提供监管协助;一个临床前级载体生产核心实验室;一个腺相关病毒（AAV）临床级载体生产核心实验室;一个慢病毒临床级载体生产核心实验室;以及一个药理学/毒理学核心实验室。