The Human Islet Distribution Coordinating Center (UC4)

描述(由申请人提供)：人的胰岛是一个重要的和宝贵的研究资源，使研究人员能够解决与糖尿病的预防、治疗和病理生理学有关的基础科学和临床问题。虽然使用替代细胞来源的实验正在产生大量数据，但过去十年的研究已经确立了显著的差异，强调了人类胰岛的重要性和不可替代的性质。然而，在建立和维护必要的基础设施和协调职能以有效和高效地将这一宝贵资源分配给小岛研究实验室方面存在一些挑战。希望之城正在申请UC4机制，以保持协调中心的地位，以支持综合胰岛分配计划(IIDP)，该计划为生物医学研究提供人类身体胰岛的分配。我们的应用程序利用了NIH在过去十年中所做的大量投资，该投资已经在希望之城建立并成功维护了这个小岛分销网络。作为正在进行的协调中心，我们将继续转包合格的胰岛隔离设施，在我们的支持和先进的电子数据系统的支持下准备和分发人类胰岛。我们的协调中心团队将继续管理IIDP申请流程，以确定接收胰岛的资格，维护一份获准接收胰岛的调查人员名册，并进一步增强我们的岛屿分配系统，该系统允许配送中心在线广播报价，并通知已批准的等待研究人员胰岛可用情况。我们将通过向胰岛研究人员收取订阅费来继续现有的部分成本回收系统，到目前为止，已成功筹集到930,800美元，以帮助抵消胰腺加工的费用。我们将继续通过我们的质量控制面板和数据、批量测试发布信息、强制性用户反馈表以及胰岛计数和运输等流程的标准化操作程序，继续密切监测和帮助提高分发的胰岛的质量。通过我们久经考验的最先进的管理、商业、技术、统计和信息学流程和工具，该项目 将确保进行特发性糖尿病研究的研究人员可以进入人体胰岛。从高质量供应商的资格和审计到预测、跟踪和满足调查人员的需求，我们经验丰富的希望之城团队在这笔赠款中建议与19个不同的隔离实验室合作，以协调 在10年时间里，近1.6亿个小岛相当于170名基础科学家，促进了350多项研究的完成和发表。如果获得这笔资金，我们在本申请中描述的3个目标将为糖尿病研究社区提供不可或缺的研究服务，确保IIDP网络保持稳定、技术最新、不断增强、标准化和质量不断提高，并充分响应社区的小岛需求，从而促进下一代糖尿病预防和治疗的科学实验。 与公共卫生相关：糖尿病患者经历了严重的原发和继发并发症，2007年美国的年成本估计为1740亿美元。人类胰岛在这种疾病的病理学中的核心重要性，以及它被证明作为无与伦比的实验和治疗资源的用途，导致了对胰岛制剂的需求不断上升。维持一个大规模的胰岛分布网络对于为研究人员提供访问这一宝贵资源、推动糖尿病研究领域的发现和进展至关重要。

DESCRIPTION (provided by applicant): Human pancreatic islets are an essential and precious research resource that allows investigators to address basic science and clinical questions related to the prevention, treatment, and pathophysiology of diabetes mellitus. While experiments employing alternative cellular sources are yielding considerable data, studies in the last decade have established remarkable differences that emphasize the importance and irreplaceable nature of human islets. However, several challenges exist in establishing and maintaining the necessary infrastructure and coordinating functions to effectively and efficiently distribute this precious resource to islet research laboratories. City of Hope is applying to this UC4 mechanism to remain the coordinating center to support the Integrated Islet Distribution Program (IIDP) that provides for the distribution of human cadaveric islets for biomedical research. Our application leverages the significant investment made by NIH over the last decade that has established and successfully maintained this islet distribution network at City of Hope. As the ongoing Coordinating Center, we will continue to subcontract with qualified islet isolation facilities to prepare and distribute human islets with our support and advanced electronic data systems. Our Coordinating Center team will continue to manage the IIDP application process to establish eligibility to receive islets, maintain a roster of investigators approved to receive islets, and further enhance our Islet Allocation System that allows distribution centers to broadcast offers online and notifies approved waiting researchers of islet availability. We will continue the existing partial cost recovery system through subscription fees collected from islet researchers, which has successfully garnered $930,800 to help offset the expense of pancreas processing to date. We will continue to closely monitor and help to improve the quality of islets distributed, through our quality control panel and data, batch test release information, mandatory User Feedback Forms, and standardized operating procedures for processes such as islet counting and shipping. Through our proven state-of-the-art administrative, business, technical, statistical, and informatics processes and tools, this project will secure the accessibility of human islets for investigators conducting essential diabetes mellitus research. From qualification and auditing of high-quality suppliers to forecasting, tracking, and meeting the needs of investigators, our experienced City of Hope team proposed in this grant has worked with 19 different isolation laboratories to coordinate the distribution of nearly 160 million islet equivalents to 170 basic scientists over a period of 10 years, facilitatin the completion and publication of over 350 studies. If awarded this grant, our 3 aims described in this application will provide an indispensable research service to the diabetes research community by ensuring that the IIDP network remains stable, up-to-date technologically, continually enhanced with improved standardization and quality, and fully responsive to the islet needs of the community, thus promoting the next generation of scientific experimentation toward prevention and treatment of diabetes. PUBLIC HEALTH RELEVANCE: Individuals with diabetes experience significant primary and secondary complications, at a 2007 estimated annual cost of $174 billion dollars in the United States. The central importance of human islets in the pathology of this disease, and its demonstrated use as an unparalleled experimental and treatment resource, has led to an escalating demand for islet preparations. Maintenance of a large scale islet distribution network is critical to provide researchers with access to this precious resource, advancing the discoveries and progress in the field of diabetes mellitus research.