CLINICAL TRIAL: ISLET CELL TRANSPLANTATION IN PATIENTS WITH TYPE I DIABETES

临床试验：I 型糖尿病患者的胰岛细胞移植

• 批准号: 8167147
• 负责人: Kenneth Lewis Brayman
• 金额: $ 0.4万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167147
• 关键词: Alberta province; Animal Model; Caring; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Diabetes Mellitus; Diagnostic; Early Diagnosis; Evaluation; Functional disorder; Funding; Grant; Hospitalization; Human; Hypoglycemia; Immunosuppression; Immunosuppressive Agents; Infusion procedures; Institution; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Investigation; Islet Cell; Islets of Langerhans; Islets of Langerhans Transplantation; Kidney Transplantation; Liver; Monitor; OGTT; Operative Surgical Procedures; Outcome; Patients; Pharmaceutical Preparations; Procedures; Protocols documentation; Research; Research Personnel; Resources; Source; Surgical complication; Techniques; Transplantation; United States National Institutes of Health; Universities; Virginia; glucose monitor; improved; intravenous glucose tolerance test; islet; success; type I diabetic

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. The success of pancreatic islet cell transplantation in animal models has culminated in the experimental procedure being performed in human type I diabetic human recipients. The outcome of clinical islet transplant has been variable, but more recently the majority of recipients are free from insulin therapy one year after transplantation. The avoidance of surgical complications through the percutaneous infusion of isolated islet cells into the liver promises a safer mode of transplantation and less need for post surgical care and hospitalization. The recent success of the University of Alberta when using new combinations of immunosuppressive drugs has led to new enthusiasm amongst transplant groups. This procedure, known as the Edmonton Protocol, has demonstrated improved success with a number of patients successfully remaining off insulin for over 3 years. The islet transplant protocol at the University of Virginia will focus on 3 groups of recipients, all with hypoglycemic unawareness. Non-uremic patients islet transplant alone (ITA), islet transplant after renal transplantation while patients are already taking immunosuppressants (IAK) and a simultaneous islet-kidney transplant in uremic patients (SIK). For all three groups of recipients, we hypothesize the close monitoring of islet function using continuous glucose monitoring techniques will allow early detection of islet dysfunction and more formal investigation (OGTT, IVGTT), which, if determined to be abnormal, will allow further diagnostic evaluation of donor specific reactivity and possible intervention such as exogenous insulin administration or the addition of more immunosuppression.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 胰岛细胞移植在动物模型中的成功，在人类I型糖尿病患者的实验过程中达到了顶峰。临床胰岛移植的结果一直是多种多样的，但最近大多数受者在移植后一年没有接受胰岛素治疗。通过将分离的胰岛细胞经皮注入肝脏来避免手术并发症，保证了一种更安全的移植模式，并减少了对手术后护理和住院的需要。艾伯塔大学最近在使用新的免疫抑制药物组合方面取得的成功，在移植团体中引发了新的热情。这一被称为埃德蒙顿方案的程序已经证明了更大的成功，许多患者成功地停用胰岛素超过3年。弗吉尼亚大学的胰岛移植方案将集中在三组受体身上，这些受者都没有意识到低血糖。非尿毒症患者单独进行胰岛移植(ITA)，肾移植后进行胰岛移植，同时患者已经在服用免疫抑制剂(IAK)，尿毒症患者同时进行胰岛-肾脏移植(SIK)。对于所有三组受者，我们假设使用连续血糖监测技术密切监测胰岛功能将有助于早期发现胰岛功能障碍，并进行更正式的检查(OGTT、IVGTT)，如果被确定为异常，将允许进一步诊断评估供者的特异性反应和可能的干预措施，如外源性胰岛素注射或添加更多的免疫抑制。