TRANSPLANTATION ALONE (ITA) IN PATIENTS WITH DIFFICULT CONTROL TYPE I DIABETE

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项多中心研究旨在确定门脉内胰岛移植在难以控制1型糖尿病的患者中的安全性和有效性，使用两步法分离的胰岛和非糖皮质激素免疫抑制方案。患者将被仔细监测与该程序相关的不良事件的发展。在两年的随访中，还将经常进行详细的代谢跟踪测试，以评估胰岛移植物的功能，包括IVGTT、精氨酸刺激试验、OGTT、葡萄糖钳夹和胰岛素振荡研究。这项申请要求支持在港湾-加州大学洛杉矶分校移植的受试者，以及支持整个财团的实验室测量。所要求的实验室支持是测量在这些过程中提取的葡萄糖、胰岛素、C肽、胰岛素原和胰升糖素。来自NCRR/JDRF的资金仅包括胰岛准备的费用，不支持该试验的临床方面

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This multi-center study is designed to determine the safety and efficacy of intraportal islet transplantation in patients with difficult to control type 1 diabetes using islets isolated by the two-step method and a glucocorticoid-free immunosuppressive regimen. Patients will be carefully monitored for the development of adverse events related to the procedure. Detailed metabolic follow-up tests will also be conducted frequently during the two-year follow-up to assess islet graft function, including IVGTT, arginine stimulation test, OGTT, glucose clamp, and insulin oscillation studies. This application requests support for subjects transplanted at Harbor-UCLA as well as support for laboratory measurements for the entire consortium. The lab support requested is to measure glucose, insulin, C-peptide, proinsulin and glucagon drawn during these procedures. Funding from the NCRR/JDRF covers the cost of islet preparation only, and does not support clinical aspects of this trial