Dendritic Cell Core

树突状细胞(DC)核心的运作将由私营部门免疫网站公司负责 匹兹堡大学医学中心(UPMC)和 当地投资集团。免疫站点公司与匹兹堡唯一的GMP工厂签订了分包合同，即， UPMC免疫监测和细胞产品实验室(IMCPL)，用于临床级培养 华盛顿特区。根据现有分包合同的条款，作为GMP设施的IMCPL将履行所有 支持临床TDALS所需的工作，这些TDALS建议使用自体感染的凋亡细胞 并喂给极化的DC 1作为疫苗，供同时接受HAART治疗的艾滋病毒受试者使用。这个 核心D的目标是：(1)进行临床前研究，旨在选择DC的体外条件 并优化使用自给自足的Astrom Replicell系统培养人DC和 他们感染自体艾滋病毒的年限2；(2)将这些优化的方法应用于大规模 在第三年和第四年计划作为项目3的一部分的临床试验的临床产品的产生；和(3)连续 使用最先进的单个细胞，监测接受疫苗治疗的受试者的艾滋病毒特异性反应 外周循环中HIV特异性T细胞频率的测量方法。具体地说，核心D 是否将培养和表型/功能表征DC用于治疗，并通过喂养这些DC来制备疫苗 树突状细胞有自体HIV感染的凋亡性淋巴细胞。核心D将负责文化和 含HIV的自体T淋巴细胞的扩增，在摄取凋亡的Uc细胞之前的HIV灭活 DC以及用于治疗的DC-cell产品的质量和无菌。它还将采购和 处理在临床方案过程中采集的外周血细胞或体液，检测这些 样本，产生免疫数据，并将剩余细胞分发给参与调查的人员。《核心》 将确保其生成的所有蜂窝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。

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.