Cell Therapy and Monitoring Core

细胞治疗和监测核心

• 批准号: 8310805
• 负责人: Jeffrey S. Miller
• 金额: $ 32.59万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8310805
• 关键词: Biology; Biometry; Cell Therapy; Cells; Clinical; Clinical Research; Clinical Trials; Collection; Data; Human Resources; Immune; Immunologic Monitoring; Investigational Therapies; Monitor; Natural Killer Cells; Outcome; Patients; Process; Regulatory T-Lymphocyte; Research; Research Personnel; Research Support; Resource Sharing; Sampling; Services; Stem cells; Translational Research; Transplantation; Work; base; data management; human stem cells; large scale production; novel; programs; sample collection; success

The aim of this core is to provide state of the art translational research support services for the novel cellular and immune-based therapies described in the projects in this proposal. Specifically, Core C personnel will perform the large scale production of the NK cell, Treg and Tprog products for the clinical trials in a GMP facility. The Core will also be responsible for the comprehensive immune monitoring of patient and product samples to assess the success of the novel experimental therapies described in Project 1 (T regulatory cells, PI: JE Wagner) and Project 3 (NK cells, PI: JS Miller). Core personnel work closely with the research staff from Core A (Administration) and with the biostatistics and data management staff (Core B: Biostatistics) to facilitate collection and tracking of clinical research samples and provide investigators with complete and accurate immune monitoring data which can be integrated with clinical outcome data. The Specific Aims of Core C are: 1. To perform large-scale production of NK, Treg and Tprog cells products in a GMP facility 2. To monitor the quality of clinical GMP products 3. To perform comprehensive immune monitoring of patient samples 4. To assist with integration of research and clinical outcome data

该核心的目的是为本提案项目中描述的新型细胞和免疫疗法提供最先进的转化研究支持服务。具体而言，核心C人员将在GMP设施中进行用于临床试验的NK细胞、Treg和Tprog产品的大规模生产。核心还将负责对患者和产品样本进行全面的免疫监测，以评估项目1（T调节细胞，PI：JE瓦格纳）和项目3（NK细胞，PI：JS米勒）中描述的新型实验性疗法的成功。核心人员与核心A（管理）的研究人员以及生物统计学和数据管理人员（核心B：生物统计学）密切合作，以促进临床研究样本的收集和跟踪，并为研究者提供完整准确的免疫监测数据，这些数据可以与临床结局数据相结合。 核心C的具体目标是： 1.在GMP设施中进行NK、Treg和Tprog细胞产品的大规模生产 2.监测临床GMP产品的质量 3.对患者样本进行全面的免疫监测 4.协助整合研究和临床结局数据