Dendritic Cell Core

树突状细胞核心

• 批准号: 8091775
• 负责人: CHARLES R RINALDO
• 金额: $ 4.17万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-02 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8091775
• 关键词: Dendritic Cells

The operation of Dendritic Cell (DC) Core will be the responsibility of ImmunoSite, Inc., a private sector laboratory established as a joint venture between the University of Pittsburgh Medical Center (UPMC) and a local investment group. ImmunoSite, Inc. has a subcontract with the only GMP facility in Pittsburgh, i.e., Immunologic Monitoring and Cellular Products Laboratory (IMCPL) at the UPMC, for culture of clinical-grade DC. Under the terms of the existing subcontract, the IMCPL, functioning as a GMP facility, will perform all the work necessary for supporting the clinical tdals, which propose to use apoptotic cells infected with autologous HIV and fed to polarized DC 1 as a vaccine for HIV subjects concurrently undergoing HAART therapy. The objectives of Core D are: (1) to perform pre-clinical studies designed to select the ex vivo conditions for DC polarization and to optimize the use of a self-contained Aastrom Replicell System for culture of human DC and their infection with autologous HIV in years land 2; (2) to apply these optimized methodologies to a large-scale clinical product generation for clinical trials planned as part of project 3 during years 3 and 4; and (3) to serially monitor HIV-specific responses in subjects treated with the vaccine, using the state-of-the-art single cell methods for frequency measurements of HIV-specific T-cells in the peripheral circulation. Specifically, Core D will culture and phenotypically/functionally characterize DC for therapy and prepare vaccines by feeding these DC with apoptotic lymphocytes infected with autologous HIV. Core D will be responsible for culture and expansion of HIV-containing autologous T lymphocytes, HIV inactivation prior to the uptake of apoptoUc cells by DC and for the quality as well as sterility of the DC-cell products destined for therapy. It will also procure and process peripheral blood cells or body fluids harvested in the course of the clinical protocols, assay these specimens, generate immune data and distribute remaining cells to the participating investigators. The Core will ensure that all cellular products it generates and samples it collects are accompanied by appropriate documentation that will permit linking laboratory analyses with clinical results.

树突状细胞（DC）核心的操作将由ImmunoSite，Inc.负责，一个私营部门 匹兹堡大学医学中心（UPMC）和一家 地方投资集团。ImmunoSite，Inc.拥有匹兹堡唯一的GMP设施，即， UPMC的免疫监测和细胞产品实验室（IMCPL），用于培养临床级 DC.根据现有的GMP条款，IMCPL作为GMP设施，将执行所有 支持临床tdals所必需的工作，其建议使用感染自体的凋亡细胞 HIV并喂入极化DC 1作为同时接受HAART治疗的HIV受试者的疫苗。的 核心D的目的是：（1）进行临床前研究，旨在选择DC的离体条件 极化，并优化使用自含Aastrom复制细胞系统培养人DC， 他们感染自体艾滋病毒的年土地2;（2）应用这些优化的方法，以大规模 在第3年和第4年期间，为计划作为项目3一部分的临床试验生成临床产品;以及（3）连续 使用最先进的单细胞检测技术， 外周循环中HIV特异性T细胞的频率测量方法。核心D 将培养和表型/功能表征用于治疗的DC，并通过喂养这些DC来制备疫苗。 自体HIV感染的凋亡淋巴细胞的DC。核心D将负责文化和 扩增含HIV的自体T淋巴细胞，在通过免疫细胞化学法摄取抗HIV细胞之前HIV灭活， DC和用于治疗的DC细胞产品的质量以及无菌性。它还将采购和 处理在临床方案过程中收获的外周血细胞或体液， 样本，生成免疫数据，并将剩余的细胞分发给参与研究的研究者。核心 将确保其产生的所有细胞产品和收集的样本都附有适当的 允许将实验室分析与临床结果联系起来的文件。