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

难以控制的 I 型糖尿病患者的单纯移植 (ITA)

• 批准号: 7606168
• 负责人: ELI IPP
• 金额: $ 0.32万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606168
• 关键词: Adverse event; Arginine; C-Peptide; Clinical; Computer Retrieval of Information on Scientific Projects Database; Development; Funding; Glucagon; Glucocorticoids; Glucose; Grant; Immunosuppressive Agents; Institution; Insulin; Insulin-Dependent Diabetes Mellitus; Islets of Langerhans Transplantation; Laboratories; Measurement; Measures; Metabolic; Methods; Monitor; OGTT; Patients; Preparation; Procedures; Proinsulin; Request for Applications; Research; Research Personnel; Resources; Safety; Source; Testing; Transplantation; Treatment Protocols; United States National Institutes of Health; cost; design; follow-up; glucose and insulin clamps; graft function; intravenous glucose tolerance test; islet

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项多中心研究旨在确定门静脉内胰岛移植在难以控制的1型糖尿病患者中的安全性和有效性，使用两步法分离的胰岛和无糖皮质激素的免疫抑制方案。将仔细监测患者是否发生与手术相关的不良事件。在2年随访期间，还将频繁进行详细的代谢随访试验，以评估胰岛移植物功能，包括IVGTT、精氨酸刺激试验、OGTT、葡萄糖钳夹和胰岛素振荡研究。该应用程序要求支持在Harbor-UCLA移植的受试者以及支持整个联盟的实验室测量。要求的实验室支持是测量这些手术期间抽取的葡萄糖、胰岛素、C肽、胰岛素原和胰高血糖素。来自NCRR/JDRF的资金仅涵盖胰岛制备的费用，不支持本试验的临床方面。