ISOLATION AND DISTR OF HIGH QUALITY HUMAN PANCRE*

描述(申请人提供)：该大学的移植项目 宾夕法尼亚大学(UP)长期以来一直对应用 胰岛移植在糖尿病治疗中的应用这个 该计划继续对胰岛的生物屏障进行基础调查 移植，重点是诱导免疫耐受。 从实验性胰岛移植中获得的见解导致了最近 这一疗法的成功应用和正常血糖在 I型糖尿病患者。基于这些进展，一个 UP建立了全面的胰岛移植计划 整合一支由调查科学家和 在糖尿病研究和移植方面拥有公认专业知识的临床医生。 自1999年该方案开始实施以来，已取得重大进展。 在建设其关键组成部分：1)建设一个食品和药品 符合现行良好生产规范(CGMP)的管理规范(FDA) 专门用于胰岛加工的设施；2)招聘和培训 有资格执行胰岛隔离和分配专职人员的人员 身体胰腺原位修复的移植外科医生；3) 与当地器官采购部门建立强有力的合作关系 本组织，这导致采购显著增加 人身体胰腺；4)分离的胰岛在 从事糖尿病研究的区域和国家调查人员；以及 5)制定标准化的胰岛质量指数。 在本应用程序中，这一强大的基础设施将充当 提高人身体胰腺利用率的机制 适用于制备离体胰岛。这个目标一定会实现的 通过从扩大的捐赠者池中购买胰腺，包括非心脏跳动 器官捐赠者。该计划的另一个重点将是精细化 胰岛质量指数，基于生理、生化和 与胰岛预后相关的形态参数 移植。有了这个强大的平台，该计划将准备好 实现其生产大量高纯度和 I型胰岛素依赖型人胰岛移植的质量控制 糖尿病患者。

DESCRIPTION (Provided by applicant): The transplant program at the University of Pennsylvania (UP)has had a long-standing interest in the application of pancreatic islet transplantation in the treatment of diabetes mellitus. The program has continued basic investigations of the biological barriers to islet transplantation, with emphasis on the induction of immunological tolerance. Insights gained from experimental islet transplantation have led to recent successful applications of this therapy and achievement of euglycemia in patients with Type I diabetes mellitus. Based on these advances, a comprehensive islet transplantation program was established at the UP integrating a multidisciplinary team of investigative scientists and clinicians with recognized expertise in diabetes research and transplantation. Since the inception of the program in 1999, significant progress has been made in building its critical components: 1) construction of an Food and Drug Administrative (FDA)-compliant current good manufacturing practices (cGMP) facility devoted exclusively to islet processing; 2) recruitment and training of personnel qualified to perform islet isolation and assignment of dedicated transplant surgeons for on-site recovery of cadaveric pancreata; 3) establishment of a strong collaboration with the local organ procurement organization, which has led to a marked increase in the procurement of the human cadaveric pancreata; 4) distribution of isolated pancreatic islets to regional and national investigators engaged in diabetes research; and 5) development of a standardized islet quality index. In the present application, this strong infrastructure will serve as the mechanism for increasing the availability of human cadaveric pancreata suitable for preparation of isolated islets. This goal will be accomplished by procurement of pancreata from an expanded donor pool, including non-heart-beating organ donors. Another emphasis for the program will be the refinement of the islet quality index, based on physiological, biochemical, and morphological parameters, for correlation with the outcome of islet transplantation. With this strong platform in place, the program is poised to realize its goal of generating large quantities of highly purified and quality-controlled human islets for transplantation into Type I insulin-dependent diabetic patients.