ISLET-CELL RESOURCES CTR OF SOUTHERN CALIFORNIA

描述：陈述申请的广泛、长期目标和具体目标，并参考项目的健康相关性。描述 简要介绍了实现这些目标的研究设计和方法。避免总结过去的成就和使用第一人称。本说明书 是为了作为一个简洁和准确的描述拟议的工作时，从申请分开。如果申请获得资助，则此描述， 将成为公共信息。因此，不包括专有/机密信息。不要超过所提供的空间。 这一应用将有助于开发全国最大的胰岛细胞分离和分配中心。Tto 目前的RFA促进了多个关键资源的统一，以建立这一奋进。这一努力的贡献者 包括：（1）一个具有近10年胰岛分离和移植经验的胰岛分离和移植实验室， （加州大学洛杉矶分校-弗吉尼亚州医学中心）; 2）在美国最大的学术良好生产加工（GMP）设施 美国，位于希望之城（COH）国家医疗中心，一个在糖尿病研究方面有着悠久历史的机构， 细胞生物学研究和骨髓移植研究（免疫抑制方案）， 一个地理区域，附近人口超过1700万，大约3300万： 全州范围内，与周边国家的良好航空运输; 3）六个地方之间的财团协议 一般临床研究中心（GCRC）和卫星进行胰岛细胞移植和表征， 在多达14个移植中心移植的患者的代谢过程; 4）主要的器官获取组织 （SCOPC），每年可采购350个胰腺，成功合作后可采购600多个胰腺 与其他全州器官采购组织（OPO）;和，5）存在许多全州学术 正在进行胰岛细胞研究的机构，可以受益于南加州胰岛细胞资源（SC-ICR 中心有了这些优秀的资源，SC-ICR致力于建立以下：1）隔离和 第一年分布多达75个胰腺，第四年超过200个胰腺; 2）技术进步 胰岛细胞增殖和冷冻保存技术，以允许多个供体使用或重复胰岛移植， 储存或增殖的细胞; 3）胰岛分离的技术进步，以提高产量和功能; 4 与当地OPO和器官共享联合网络（UNOS）互动，制定新的器官分配政策 并减少/消除整个器官与胰岛的“临床级”胰腺的不公平分布 移植;和，5）预测潜在的移植物排斥反应和新的免疫的研究方法的发展 耐受性策略，以减少对免疫抑制方案的依赖。因此，常设委员会国际民事代表的启动将B 有助于推进胰岛细胞生理学和治疗应用领域。通过这一努力， 战胜1型糖尿病，将更接近实现。 履约地点（组织、城市、州）。 贝克曼研究所希望之城 San Francisco，CA 关键人员。参见第页上的说明 名称 亚瑟·里格斯博士 Fouad Kandeel，医学博士，博士 医学博士克雷格史密斯 琳达舍夫林 大卫伊克尔博士 Ivan Todorov博士 Yoko马伦，医学博士，博士 大卫迪朱斯托博士 Tom Balon博士 医学博士霍华德马克思 Pinchas Cohen，医学博士 小罗伯特·费里，M.D. 拉马·纳塔拉詹博士 医学博士大卫布莱希 Eli Ipp，医学博士 11.根据需要使用续页，以下列格式提供所需信息。 .组织在项目中的作用 City of Hope首席研究员 City of Hope首席研究员 UCLA/City of Hope联合首席研究员 UCLA/City of Hope Center协调员 City of Hope注册处处长 加州大学洛杉矶分校/希望之城胰岛隔离主任 UCLA / City of Hope质量控制总监 City of Hope质量控制（GMP）联席总监 City of Hope质量控制联席总监 City of Hope有创放射学联合研究员 UCLA项目首席研究员 UCLA项目首席研究员 希望之城项目首席研究员 City of Hope发展研究主任 Harbor-UCLA发展研究联合主任 PHS 398（Rev. 4/98）第2 BB页 在整个应用程序的底部连续编号页面。不要使用后缀，如3a，3b。

DESCRIPTION: State the application's broad, long-term objectives and specific aims, making referenceTWhe health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This description is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. This application will aid the development of the largest islet-cell isolation and distribution center in the nation. Tto present RFA catalyzed the unification of multiple key resources to establish this endeavor. Contributors to this effort include: 1) An islet isolation and transplantation laboratory with nearly 10 years experience in islet-sharing progra (UCLA-VA Medical Center); 2) The largest academic Good Manufacturing Processing (GMP) facility in the Unitei States, located at City of Hope (COH) National Medical Center, an institution with a long history in diabetes research, cell biology research, and bone marrow transplantation research (immunosuppressive regimens), conveniently situated i a geographic area with a population of more than 17 million in the immediate vicinity and approximately 33 millio: statewide, with excellent air transportation to surrounding states; 3) An agreement for a consortium between six loca General Clinical Research Centers (GCRCs) and satellites to conduct islet cell transplantation and characterization oi metabolic processes in patients transplanted at up to 14 transplant centers; 4) A major organ harvesting organization (SCOPC) with the potential of procuring 350pancreata annually, and over 600 pancreata upon successful collaboration with other statewide organ procurement organizations (OPOs); and, 5) The existence of many statewide academic institutions with ongoing islet-cell research that can benefit from the Southern California Islet-Cell Resources (SC-ICR Center. With these outstanding resources, the SC-ICR is committed to establish the following: 1) Isolation anc distribution of up to 75 pancreata in the first year and more than 200 pancreata by year 4; 2) Technologic advancement of islet-cell proliferation and cryopreservation techniques to allow for multiple donor use or repeated islet transfer from stored or proliferated cells; 3) Technologic advancement of islet isolation to improve yield and functionality; 4 Interaction with local OPOs and the United Network for Organ Sharing (UNOS) to develop new organ allocation policies and reduce/eliminate the inequitable distribution of "clinical grade" pancreata for whole organ versus islet transplantation; and, 5) Development of investigative methods for predicting potential graft rejection and new immum tolerance strategies to reduce dependency on immunosuppressive regimens. Thus, the inception of the SC-ICR will b instrumental in advancing the field of islet-cell physiology and therapeutic use. Through this effort, the dream o conquering Type 1 diabetes mellitus and will be closer to realization. PERFORMANCE SITE(S) (organization, city, state) . Beckman Research Institute City of Hope Duarte, CA KEY PERSONNEL. See instructions on Page Name Arthur Riggs, Ph.D. Fouad Kandeel, M.D., Ph.D. Craig Smith, M.D. Linda Shevlin David Ikle, Ph.D. Ivan Todorov, Ph.D. Yoko Mullen, M.D., Ph.D. David DiGiusto, Ph.D. Tom Balon, Ph.D. Howard Marx, M.D. Pinchas Cohen, M.D. Robert Ferry, Jr., M.D. Rama Natarajan, Ph.D. David Bleich, M.D. Eli Ipp, M.D. 11. Use continuation pages as neededto provide the required information in the format shown below. .Organization Role on Project City of Hope Principal Investigator City of Hope Co-Principal Investigator UCLA/City of Hope Co-Principal Investigator UCLA/City of Hope Center Coordinator City of Hope Director of Registry UCLA/City of Hope Director of Islet Isolation UCLA / City of Hope Director of Quality Control City of Hope Co-Director of Quality Control (GMP) City of Hope Co-Director of Quality Control City of Hope Co-Investigator of Invasive Radiology UCLA Project Lead Investigator UCLA Project Lead Investigator City of Hope Project Lead Investigator City of Hope Co-Director of Developmental Research Harbor-UCLA Co-Director of Developmental Research PHS 398 (Rev. 4/98) Page 2 BB Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b.