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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本多中心研究旨在通过两步法分离胰岛和无糖皮质激素免疫抑制方案，确定难以控制的1型糖尿病患者门静脉内胰岛移植的安全性和有效性。将仔细监测患者是否发生与手术相关的不良事件。在为期两年的随访期间，还将经常进行详细的代谢随访试验，以评估胰岛移植功能，包括IVGTT、精氨酸刺激试验、OGTT、葡萄糖钳和胰岛素振荡研究。该申请要求支持在港-加州大学洛杉矶分校移植的受试者以及支持整个联盟的实验室测量。所要求的实验室支持是测量在这些过程中绘制的葡萄糖、胰岛素、c肽、胰岛素原和胰高血糖素。来自NCRR/JDRF的资金仅用于胰岛制备的费用，而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