CLINICAL TRIAL: ISLET TRANSPLANTATION ALONE (ITA) IN PATIENTS WITH DIFFICULT TO

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。 本研究的目的是评估胰岛细胞移植在诊断为无肾功能衰竭的难以控制的1型糖尿病患者中的安全性和有效性。难以控制的1型糖尿病被定义为尽管正确使用标准的胰岛素治疗和频繁的血糖监测，但血糖的大幅波动扰乱了患者的生活，并导致频繁的低血糖发作。 1型糖尿病与特定的胰岛细胞亚型受损有关，这使患者依赖外部胰岛素来源。尽管接受了胰岛素治疗，但存在出现长期问题的重大风险，包括对心脏、血管、神经、眼睛和肾脏的损害。最近的研究结果表明，这些并发症是由血糖控制不佳引起的。胰岛移植提供了良好的血糖控制前景，而没有与整个胰腺移植相关的主要手术风险，并可能导致独立于胰岛素注射。最近，加拿大埃德蒙顿的一组研究人员使用了一种抗排斥药物的组合来帮助防止移植胰岛的排斥反应，结果显示，该方案对超过75%的病例有效，他们被随访了20个月。这项研究是为了证实埃德蒙顿研究的结果，以确定单独进行胰岛移植是否是治疗1型糖尿病患者的一种安全有效的方法。

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 purpose of this study is to evaluate the safety and effectiveness of islet cell transplantation alone in patients diagnosed with difficult to control Type 1 diabetes mellitus without kidney failure. Difficult to control Type 1 diabetes is defined as wide swings in blood glucose that disrupt the patient's life and result in frequent episodes of low blood glucose despite the proper use of standard insulin therapy and frequent blood glucose monitoring. Type 1 diabetes is associated with the damage of a specific cell subtype of pancreatic islets, which makes patients depend on an outside source of insulin. Despite insulin treatment, there is a significant risk of long-term problems, including damage to the heart, blood vessels, nerves, eyes and kidneys. The results of recent research studies suggest that these complications are caused by poor glucose control. Transplantation of islets offers the prospect of good glycemic control without the major surgical risks associated with whole pancreas transplant and may result in independence from insulin injections. Recently, a group of investigators in Edmonton, Canada used a combination of anti-rejection drugs to help prevent the rejection of transplanted islets and showed that the regimen was effective in more than 75% of the cases who were followed up to 20 months. This study is being performed to confirm the results of the Edmonton study to see if islet transplantation alone is a safe and effective way of treating patients with type 1 diabetes.