Core C: Cell Processing and Immune Monitoring Core

核心 C：细胞处理和免疫监测核心

基本信息

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
项目类别：
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

项目摘要

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研究人员进行标准化使用这些资源。 Core C 在细胞制备过程中提供技术专业知识和监管支持用于临床试验的产品，包括产品操作和表征、质量管理和工艺文档。这项支持将由斯坦福医疗保健细胞治疗机构 (CTF) 提供。经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 提供符合当前良好组织规范 (cGTP) 的细胞疗法处理和当前的良好生产规范 (cGMP)。 Core C的一个重要功能就是促进交互通过协助细胞的转化开发，在该计划的临床和研究部门之间建立联系基于临床前模型的疗法。核心 C 促进组织库并管理样本分配调查人员。通过 CTF 和斯坦福 Spectrum 生物库之间的合作安排，Core C 将支持一个基于项目的组织库，包括从供体移植物、细胞产品和移植前和移植后的血液样本供项目团队长期储存和使用。核心C提供 T 细胞受体库的标准化免疫监测，并促进其他专门免疫的使用通过现有机构共享核心设施进行分析。基于我们过去对平台的 Core C 优化为了测量TCR Vb CDR3库，我们将为每个项目提供标准化的TCR测序，并提供目标是在同一环境中评估供体移植物、实验细胞产品和移植后样本每个项目的方式。我们还将协助每个项目获取和使用免疫资源通过人类免疫监测核心 (HIMC) 和基因组学服务中心进行监测。在总之，这个核心有助于将 PPG 集成到斯坦福大学建立的大型基础设施中进行并科学监测细胞治疗临床试验，从而避免不必要的重复资源并提高效率。