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）核心的运行将是私营部门Immunosite，Inc。的责任 实验室是匹兹堡大学医学中心（UPMC）与A之间的合资企业 本地投资集团。 Immunosite，Inc。与匹兹堡唯一的GMP工厂合同，即 临床级培养 DC。根据现有分包合同的条款，作为GMP功能的IMCPL将执行所有 支持临床TDAL所需的工作，该临床TDAL建议使用自体感染的凋亡细胞 艾滋病毒并将其喂入极化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 两极分化并优化使用独立的Aastrom复制系统在人类DC文化中的使用 他们在多年的土地上感染了自体艾滋病毒2； （2）将这些优化的方法应用于大规模 计划在第3年和4年内作为项目3的临床试验的临床产品生成； （3）连续 使用最新的单细胞，监测用疫苗治疗的受试者中的HIV特异性反应 外周循环中HIV特异性T细胞的频率测量方法。具体而言，核心d 将培养和表型/功能表征DC进行治疗，并通过进食这些疫苗来制备疫苗 DC患有自体HIV感染的凋亡淋巴细胞。核心D将负责文化和 在吸收apoptouc细胞之前，含有HIV的自体T淋巴细胞，HIV失活的扩展 DC，以及用于治疗的DC细胞产品的质量和不育。它也将采购和 在临床方案过程中收获的过程外周血细胞或体液，分析这些 标本，生成免疫数据并将剩余的细胞分配给参与的研究者。核心 将确保其生成的所有蜂窝产品和收集的样品均伴随着适当的 文档将允许将实验室分析与临床结果联系起来。