Clinical Core

临床核心

• 批准号: 7646827
• 负责人: Theresa L. Whiteside
• 金额: $ 2.47万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7646827
• 关键词: Apoptotic; Arts; Biological Assay; Biopsy; Blood specimen; Body Fluids; Clinical; Clinical Protocols; Clinical Trials; Collaborations; Colorectal Cancer; Cyclic GMP; Dendritic Cells; Documentation; Enrollment; Ensure; Evaluation; Generations; Human; Human body; Immune response; Immunohistochemistry; Immunologic Monitoring; Immunologics; Immunotherapy; Instruction; Laboratories; Laboratory Study; Link; Malignant Neoplasms; Measures; Monitor; Operative Surgical Procedures; Patient Monitoring; Patients; Preparation; Process; Production; Recording of previous events; Research; Research Personnel; Role; Sampling; Services; Specific qualifier value; Specimen; Specimen Handling; Sterility; T-Lymphocyte; Therapeutic Intervention; Time; Tissue Banking; Tissue Banks; Tissue Harvesting; Tissue Procurements; Tissues; Triage; Tumor Cell Line; University of Pittsburgh Cancer Institute; Vaccine Production; Vaccines; base; enzyme linked immunospot assay; melanoma; neoplastic cell; peripheral blood; preclinical study; programs; response; therapy design; tumor

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):

核心C：免疫监测和细胞产品实验室(IMCPL) 该实验室是匹兹堡大学癌症研究所(UPCI)的专门设施， 致力于治疗前、治疗中和治疗后免疫反应的最新评估 癌症患者的干预措施。除了产生用于人类治疗的细胞产品外，它还 提供纸巾采购和加工服务。作为该PPG的核心C，IMCPL将 负责支持项目提出的以免疫疗法为基础的临床试验。堆芯 C，作为cGMP设施，将培养和鉴定树突状细胞(ADc1)，用于患者治疗和 通过将凋亡的肿瘤细胞(ATC)装载到这些aDC1来制备疫苗(结直肠癌(项目1和 4)和黑色素瘤(项目1))用于治疗。核心C将负责ADC1的质量和无菌- 基础疫苗。将使用IL-12p70产生试验来测量aDC1产物的效力。核心C 还将采购和处理在临床试验过程中收集的所有体液和组织。肿瘤 手术时获得的样本或活检组织将被加工用于疫苗或将被 准备由Core B执行免疫组织化学。Core C，作为完全认证的 免疫监测设施，将通过执行以下操作来监测对接种疫苗的免疫反应 ELISPOT分析和四聚体分析。核心C还将准备协助PPG调查人员 实施评估疫苗免疫应答所需的化验。核心将确保 它产生的所有蜂窝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还将在以下方面提供援助 准备IND提交的文件。核心实验室与所有 研究人员，并在拟议的临床和临床前研究的背景下，将完全致力于 这位PPG的支持。 相关性(请参阅说明)：