Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes and Extended Follow Up after Islet Transplantation in Type 1 Diabetes

The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population was individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. The focus of CIT03 was to evaluate the investigational agent, deoxyspergualin. Subjects in CIT03 received rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), deoxyspergualin, etanercept, sirolimus, and low-dose tacrolimus in an open-label fashion.

CIT协作组（CIT consortium）在北美（CIT02至CIT08）与北欧地区（CIT01）共计开展9项研究。其中CIT08为北美研究站点针对意向参与者开展的长期随访研究。本研究的目标受试人群为1型糖尿病（type 1 diabetes）、肾功能正常且合并难治性低血糖（intractable hypoglycemia）的个体。所有研究均为受试者实施最多3次独立的胰岛输注治疗。CIT03的核心研究重点为评估试验性药物脱氧精胍菌素（deoxyspergualin）。CIT03的受试者采用开放标签给药方案，接受兔抗胸腺细胞球蛋白（rabbit anti-thymocyte globulin，ATG；若需开展第2、3次移植，则以巴利昔单抗（basiliximab）替代ATG）、脱氧精胍菌素、依那西普（etanercept）、西罗莫司（sirolimus）与低剂量他克莫司（tacrolimus）治疗。