Hematopoietic Biorepository and Cellular Therapy Shared Resource

造血生物库和细胞治疗共享资源 项目摘要/摘要 造血生物资源库和细胞治疗共享资源(血液SR)是必不可少的 Case综合癌症中心(Case CCC)成员的研究资产，由 科学项目的参与，反映在使用这一SR的大量调查人员身上。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 该中心的所有7个项目都使用了SR。造血SR的使命是提供资源和 与细胞的采购、加工、生产、储存、银行处理、分析和分配有关的服务 从人的血液、骨髓和脐带中提取。SR还运营着临床蜂窝 支持临床级细胞制造的治疗设施，用于研究和标准护理治疗。 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，以支持基本和翻译 研究。保持一个活跃的IRB以同意并获取血液和骨髓样本，以及 来自癌症患者和健康捐赠者的相关病例和组织数据，用于分发给Case CCC 调查人员。 2.协助使用者进行专门的造血细胞化验。提供指导和服务，以使 研究人员进行专门的造血细胞分析，如集落分析。 3.支持细胞疗法临床试验的开发和实施。所有服务均提供支持 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。 在最后的评价中，造血SR被评为优秀的优点。在本供资周期(2012年-- 2016年)，造血SR为106名注册用户提供服务，其中44名(42%)为Case CCC 成员，代表Case CCC的所有7个项目。 造血学SR维护了一个带注释的收集样本的生物存储库，用于研究和 协助调查人员进行专门的造血分析，如CFU分析和骨髓来源的分析 骨髓间充质干细胞分离。SR的细胞治疗组件，指定为细胞 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永久细胞 实验室操作规范(GLP)安全研究、调节途径导航、临床方案制定、 研究新药应用(IND)准备，临床级别用品和试剂的来源，以及 从研究扩展到临床操作，包括准备研究性临床治疗等级 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.