Clinical Core

核心C：免疫监测和细胞制品实验室（IMCPL） 该实验室是匹兹堡大学癌症研究所（UPCI）的一个专门设施， 致力于在治疗之前、期间和之后对免疫应答进行最先进的评价 对癌症患者的干预。除了产生用于人类治疗的细胞产物外， 提供组织采购和处理服务。作为本PPG的核心C，IMCPL将 负责支持项目提出的免疫治疗临床试验。核心 C作为cGMP设施，将培养和表征用于患者治疗的树突状细胞（aDC 1）， 通过用凋亡肿瘤细胞（ATC）装载这些aDC 1来制备疫苗（结肠直肠癌（项目1和 4)和黑色素瘤（项目1））进行治疗。核心C将负责aDC 1- 基于疫苗。将使用IL-12 p70产生测定法测量aDC 1产物的效价。芯C 也将采购和处理临床试验过程中采集的所有体液和组织。肿瘤 在手术或活组织检查时获得的标本将被处理用于疫苗或将被 由Core B进行免疫组化。核心C，作为一个完全认证的 免疫监测设施，将监测免疫反应的管理疫苗， ELISPOT测定和四聚体分析。还将准备核心C，以协助PPG研究者 实施评估疫苗免疫应答所需的测定。核心将确保 它生产的所有细胞产品和收集的样本都附有适当的文件 这将允许将实验室分析与临床结果联系起来。核心C还将提供援助， 准备IND申请。核心实验室与所有的合作有着悠久的历史， 研究者，并在拟议的临床和临床前研究的背景下，将完全致力于 支持这个PPG。 相关性（参见说明）：

Core C: Immunologic Monitoring and Cellular Products Laboratory (IMCPL) This laboratory is a specialized facility at the University of Pittsburgh Cancer Institute (UPCI), which is dedicated to the state-of-the-art evaluation of immune responses prior to, during and after therapeutic interventions in patients with cancer. In addition to generating cellular products for human therapy, it also provides services for tissue procurement and processing. In its role as Core C for this PPG, the IMCPL will assume responsibility for supporting the immunotherapy-based clinical trials proposed by the projects. Core C, functioning as a cGMP facility, will culture and characterize dendritic cells (aDC1) for patient therapy and prepare vaccines by loading these aDC1 with apoptotic tumor cells (ATC) (colorectal cancer (Project 1 and 4) and melanoma (Project 1)) for therapy. Core C will be responsible for quality and sterility of the aDC1- based vaccines. Potency of aDC1 products will be measured, using the IL-12p70 production assay. Core C will also procure and process all body fluids and tissues harvested in the course of the clinical trials. Tumor specimens obtained at the time of surgery or biopsy tissues will be processed for use in vaccines or will be banked for immunohistochemistry to be performed by Core B. Core C, serving as a fully certified immunologic monitoring facility, will monitor immune responses to the administered vaccines by performing ELISPOT assays and tetramer analyses. Core C will also be prepared to assist the PPG investigators in implementing assays necessary for evaluation of immunologic responses to vaccines. 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. Core C will also provide assistance in preparation of IND submissions. The Core laboratory has a long history of collaboration with all of the investigators, and in the context of the proposed clinical and pre-clinical studies will be entirely dedicated to the support of this PPG. RELEVANCE (See instructions):