目的探讨新型成人胰岛细胞分离、纯化技术分离的成人胰岛细胞移植治疗1型糖尿病的安全性与有效性。方法采用全氟化碳液(PFC)和UW液双层冷藏胰腺,Liberase酶消化,COBE 2991型专用胰岛细胞分离机分离及连续密度梯度纯化,获取高纯度与高活性的胰岛细胞。通过上腹部小切口,胃右静脉或脐静脉插管。将经短期培养的胰岛细胞经门静脉移植到11例1型糖尿病患者肝脏内。采用达利珠单抗或阿来佐单抗进行诱导,西罗莫司和他克莫司联用的方案预防排斥反应,术后观察胰岛素使用情况,监测血糖、C-肽与糖化血红蛋白水平以及肝功能、肾功能。结果45个胰腺中,42个成功分离出胰岛细胞,其数量平均为28.5×10~4胰岛当量(IEQ)/个,纯度为95.7%,活率为93.2%,胰岛素释放试验刺激指数为2.43。11例1型糖尿病患者共行胰岛细胞移植20次,其中移植1次4例,2次5例,3次2例,每次移植胰岛细胞数平均为11 200 IEQ/kg。术后随访6个月至4年,6例完全撤除胰岛素,2例胰岛素用量较术前减少80%,3例减少50%。术后血糖稳定维持在正常水平,C-肽均超过0.166 nmol/L,糖化血红蛋白基本正常,肝、肾功能正常,未发生与胰岛细胞输注相关的并发症。结论新型成人胰岛细胞分离、纯化方法可靠,采用该技术分离、纯化的成人胰岛细胞移植治疗1型糖尿病临床效果较好。 Objective To investigate the safety and efficacy of adult islet cell transplantation in the treatment of type 1 diabetes mellitus with isolation and purification of new adult islet cells. Methods PANC and UW liquid were used to refrigerate the pancreas, digested with Liberase, isolated with special COBE 2991 islet cell separator and purified by continuous density gradient to obtain islet cells with high purity and high activity. Through the small incision in the abdomen, right gastric vein or umbilical vein catheterization. Short-term cultured islet cells were transplanted into the livers of 11 patients with type 1 diabetes through the portal vein. Induction with daclizumab or alemtuzumab, a regimen of sirolimus and tacrolimus to prevent rejection, postoperative insulin use, monitoring of blood glucose, C-peptide and glycated hemoglobin levels, and Liver function, kidney function. RESULTS: Of 45 pancreas, 42 were successfully isolated islet cells, the average number of islets was 28.5 × 10 ~ 4 islets / unit, the purity was 95.7%, the survival rate was 93.2%, and the stimulation index of insulin release test was 2.43. Eleven patients with type 1 diabetes underwent islet cell transplantation 20 times in total. Among them, 1 was transplanted in 4 cases, 2 cases in 5 cases and 2 cases in 3 cases. The average number of islet cells per transplant was 11 200 IEQ / kg. All the patients were followed up for 6 months to 4 years. Six patients were completely withdrawn from insulin. The amount of insulin in two patients was reduced by 80% compared with that before operation and reduced by 50% in three patients. Postoperative blood glucose was maintained at normal levels, C-peptide were more than 0.166 nmol / L, HbA1c was basically normal, liver and kidney function was normal, no complications related to islet cell infusion occurred. Conclusion The method of isolation and purification of new adult islet cells is reliable. The isolation and purification of adult islet cells transplantation in type 1 diabetes mellitus is effective.