Core C: Cell Processing and Immune Monitoring Core

核心 C：细胞处理和免疫监测核心

• 批准号: 10242116
• 负责人: EVERETT MEYER
• 金额: $ 53.71万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242116
• 关键词: Blood; Blood specimen; Bone Marrow Transplantation; Cell Therapy; Cells; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Contracts; Core Facility; Development; Documentation; Drug or chemical Tissue Distribution; Ensure; Genomics; Goals; Healthcare; Human; Immune; Immunologic Monitoring; Immunology procedure; Infrastructure; Laboratories; Measurement; Measures; Monitor; Nucleotides; Performance; Pharmacists; Pre-Clinical Model; Preparation; Procedures; Process; Production; Program Research Project Grants; Research Contracts; Research Personnel; Residual Neoplasm; Resources; Sampling; Services; Specimen; Standardization; Structure of thyroid parafollicular cell; Supporting Cell; T cell receptor repertoire sequencing; T-cell receptor repertoire; Technical Expertise; Techniques; Technology; Therapy Clinical Trials; Time; Tissue Banks; Tissues; Transplantation; Universities; Validation; Vendor; arm; base; biobank; cost; leukemia/lymphoma; molecular pathology; phase 1 study; post-transplant; programs; quality assurance; therapy development

Core C (Cell Processing and Immune Monitoring Core): Project Summary/Abstract The Cell Processing and Immune Monitoring Core (Core C) will support each of the projects in this proposal by leveraging existing infrastructure at Stanford University and assisting project investigators in the standardized use of these resources. Core C provides technical expertise and regulatory support in the preparation of cellular products for clinical trials including product manipulation and characterization, quality management, and process documentation. This support will be provided by the Stanford Health Care Cellular Therapy Facility (CTF). By offsetting development and manufacturing costs, and providing support to a dedicated cellular pharmacist, Core C provides processing for cell-based therapeutics compliant with both current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP). An important function of Core C is to facilitate interaction between the clinical and research arms of the program by assisting with the translational development of cell- based therapies from pre-clinical models. Core C facilitates tissue banking and manages sample distribution to investigators. Through a collaborative arrangement between the CTF and the Stanford Spectrum Biobank, Core C will support a project-based tissue bank including collection of material from donor grafts, cell products and pre- and post-transplant blood specimens for long term storage and use by project teams. Core C provides standardized immune monitoring of the T cell receptor repertoire and facilitates use of other specialized immune assays through existing institutional shared core facilities. Building on our past Core C optimization of a platform for measuring TCR Vb CDR3 repertoire, we will provide standardized TCR sequencing to each project, with a goal of having the donor graft, experimental cell product, and post-transplant samples evaluated in the same manner for each project. We will also assist each project in accessing and using the resources for immune monitoring available through the Human Immune Monitoring Core (HIMC) and genomics service centers. In summary, this Core serves to help integrate the PPG into the large infrastructure established at Stanford for conducting and scientifically monitoring cellular therapy clinical trials, thus avoiding the unnecessary duplication of resources and enhancing efficiency.

核心C(细胞处理和免疫监测核心)：项目摘要/摘要 细胞处理和免疫监测核心(核心C)将通过以下方式支持本提案中的每个项目 利用斯坦福大学的现有基础设施，并协助项目调查人员进行标准化 这些资源的使用。核心C提供技术专业知识和法规支持，以准备细胞 用于临床试验的产品，包括产品操纵和表征、质量管理和过程 文件。这项支持将由斯坦福卫生保健细胞治疗设施(CTF)提供。通过 抵消开发和制造成本，并为专门的细胞药剂师CORE提供支持 C为基于细胞的治疗提供符合当前良好组织实践(CGTP)的处理 和现行良好制造规范(CGMP)。核心C的一个重要功能是促进交互 通过帮助细胞的翻译开发来帮助该计划的临床和研究部门- 以临床前模型为基础的治疗。核心C促进组织银行和管理样本分配到 调查人员。通过CTF和斯坦福光谱生物库之间的合作安排，CORE C将支持一个以项目为基础的组织库，包括从捐赠者移植物、细胞产品和 移植前和移植后的血液样本，供项目组长期储存和使用。核心C提供 T细胞受体谱系的标准化免疫监测，并促进其他专门免疫的使用 通过现有的机构共享核心设施进行分析。在我们过去核心C优化平台的基础上构建 对于TCR VB CDR3曲目的测量，我们将为每个项目提供标准化的TCR序列，并提供 使供体移植物、实验细胞产品和移植后样本得到相同评估的目标 每个项目的方式。我们还将帮助每个项目访问和使用免疫的资源 可通过人类免疫监测核心(HIMC)和基因组学服务中心进行监测。在……里面 总结，此核心有助于将PPG整合到斯坦福大学建立的大型基础设施中 开展和科学监测细胞治疗临床试验，避免不必要的重复 有效利用资源，提高效率。