ISLET TRANSPLANTATION ALONE (ITA) IN PATIENTS WITH DIFFICULT TO CONTROL TYPE 1

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。本研究的目的是评估单独胰岛细胞移植在诊断为难以控制的1型糖尿病无肾功能衰竭患者中的安全性和有效性。难以控制的1型糖尿病被定义为血糖的大幅波动，扰乱患者的生活，导致低血糖频繁发作，尽管正确使用标准胰岛素治疗和频繁的血糖监测。1型糖尿病与胰岛特定细胞亚型的损伤有关，这使得患者依赖于胰岛素的外部来源。尽管接受胰岛素治疗，但长期问题的风险很大，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良引起的。胰岛移植提供了良好的血糖控制前景，没有与全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抗排斥药物组合来帮助预防移植胰岛的排斥反应，结果表明，在随访20个月的病例中，该方案对75%以上的病例有效。这项研究是为了确认埃德蒙顿研究的结果，以确定单独的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.