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）核心的运营将由私营部门ImmunoSite, Inc.负责 匹兹堡大学医学中心 (UPMC) 和一家合资企业成立了实验室 地方投资集团。 ImmunoSite, Inc. 与匹兹堡唯一的 GMP 设施签订了分包合同，即 UPMC 的免疫监测和细胞产品实验室 (IMCPL)，用于临床级培养 直流。根据现有分包合同的条款，IMCPL 作为 GMP 设施，将执行所有 支持临床tdals所必需的工作，该临床tdals建议使用自体感染的凋亡细胞 HIV 并喂养极化 DC 1 作为同时接受 HAART 治疗的 HIV 受试者的疫苗。这 核心 D 的目标是：(1) 进行临床前研究，旨在选择 DC 的离体条件 极化并优化使用独立的 Aastrom Replicell 系统来培养人类 DC 和 他们在第 2 年感染自体 HIV； (2) 将这些优化方法应用于大规模 计划在第 3 年和第 4 年作为项目 3 的一部分进行临床试验的临床产品生成；和（3）串行 使用最先进的单细胞监测接受疫苗治疗的受试者的 HIV 特异性反应 外周循环中 HIV 特异性 T 细胞频率测量的方法。具体来说，核心D 将培养 DC 并对其表型/功能进行表征以用于治疗，并通过喂养这些 DC 来制备疫苗 具有感染自体 HIV 的凋亡淋巴细胞的 DC。核心 D 将负责文化和 含有HIV的自体T淋巴细胞的扩增，在凋亡细胞摄取之前灭活HIV DC 以及用于治疗的 DC 细胞产品的质量和无菌性。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，分析这些 样本，生成免疫数据并将剩余细胞分发给参与研究人员。核心 将确保其生成的所有细胞产品和收集的样本均附有适当的 允许将实验室分析与临床结果联系起来的文件。