Hematopoietic Biorepository and Cellular Therapy Shared Resource

造血生物库与细胞治疗共享资源 项目总结/摘要 造血生物储存和细胞治疗共享资源（造血SR）是一个必不可少的 资产的情况下综合癌症中心（案例CCC）成员的研究，说明了广泛的 科学计划的参与，并反映在大量的研究人员谁使用这个SR。去年 仅调查人员就超过50人，其中51%是Case CCC成员，占总使用量的68%，来自 中心的所有7个项目都使用了SR。造血SR的使命是提供资源， 与细胞的采购、加工、生产、储存、储存、分析和分配有关的服务 来源于人的血液骨髓和脐带SR还运营着一个临床细胞 支持临床级细胞生产的治疗机构，用于研究和标准治疗。 造血SR的具体目标是： 1.允许访问带注释的临床血液和骨髓样本，以支持基础和翻译 research.维持一个活跃的IRB，以同意和获取血液和骨髓样本， 来自癌症患者和健康供体的相关病例和组织数据，用于分发给病例CCC investigators. 2.帮助用户进行专门的造血细胞检测。提供指导和服务， 研究人员进行专门的造血细胞测定，如集落测定。 3.支持细胞疗法临床试验的开发和实施。所有国家都提供支助 临床细胞治疗的各个方面，从协助监管批准到监督和制造 临床级细胞 在上次审查中，造血SR被评为优秀。在本供资周期（2012- 2016年）， 2016年），造血SR为106名注册用户提供了服务，其中44名（42%）是案例CCC 成员，代表所有7个案例CCC计划。 造血SR维持一个生物储存库，储存有注释的收集样本，供研究使用， 协助研究者进行专门的造血检测，如CFU检测和骨髓源性 间充质干细胞分离。SR的细胞治疗组件，称为细胞治疗组件。 治疗服务，支持从临床前阶段到临床试验的临床细胞治疗活动 实施.支持能力包括协助设计和准备细胞， 实验室规范（GLP）安全性研究、监管途径导航、临床方案制定， 研究性新药申请（IND）准备、临床级供应品和试剂的采购，以及 从研究到临床操作的规模扩大，包括研究性临床治疗级的准备 蜂窝产品。

HEMATOPOIETIC BIOREPOSITORY AND CELLULAR THERAPY SHARED RESOURCE PROJECT SUMMARY/ABSTRACT The Hematopoietic Biorepository and Cellular Therapy Shared Resource (Hematopoietic SR) is an essential asset to Case Comprehensive Cancer Center (Case CCC) members' research, illustrated by the breadth of scientific program involvement and reflected in the large number of investigators who use this SR. Last year alone, over 50 investigators, 51% of whom were Case CCC members, accounting for 68% of total usage, from all 7 of the Center’s Programs used the SR. The mission of the Hematopoietic SR is to provide resources and services related to the procurement, processing, production, storage, banking, analysis and distribution of cells derived from human blood, bone marrow, and umbilical cords. The SR also operates a Clinical Cellular Therapy facility that supports clinical-grade cell manufacturing for investigational and standard of care therapy. The Specific Aims of the Hematopoietic SR are to: 1. Enable access to annotated clinical blood and bone marrow samples to support basic and translational research. An active IRB is maintained to consent and procure blood and bone marrow samples and related case and tissue data from cancer patients and healthy donors for distribution to Case CCC investigators. 2. Assist users with specialized hematopoietic cell assays. Guidance and services are provided to enable investigators to perform specialized hematopoietic cell assays such as colony assays. 3. Support the development and implementation of cellular therapy clinical trials. Support is provided in all aspects of clinical cell therapy, from assisting with regulatory approval to oversight and manufacture of clinical grade cells. At last review, the Hematopoietic SR was rated Excellent merit. Throughout the current funding cycle (2012- 2016), the Hematopoietic SR provided services to 106 registered users, 44 (42%) of whom are Case CCC members, representing all 7 of the Case CCC programs. The Hematopoietic SR maintains a biorepository of annotated collected samples for use in research and assists investigators with specialized hematopoietic assays such as CFU assays and bone marrow-derived mesenchymal stem cell isolation. The cellular therapy component of the SR, designated as the Cellular Therapy Service, supports clinical cellular therapy activities from the preclinical phase through clinical trial implementation. Support capabilities include assistance in the design and preparation of cells for Good Laboratory Practices (GLP) safety studies, navigation of the regulatory pathway, clinical protocol development, Investigational New Drug Application (IND) preparation, sourcing of clinical grade supplies and reagents, and scale up from research to clinical operations, including preparation of investigational clinical therapy grade cellular products.