Five-year follow-up of patients with type 1 diabetes transplanted with allogeneic islets: the UIC experience.
Five-year follow-up of patients with type 1 diabetes transplanted with allogeneic islets: the UIC experience.
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DOI：
10.1007/s00592-014-0627-6
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发表时间：
2014-10
影响因子：
3.8
通讯作者：
Oberholzer J
中科院分区：
文献类型：
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作者：
Qi M;Kinzer K;Danielson KK;Martellotto J;Barbaro B;Wang Y;Bui JT;Gaba RC;Knuttinen G;Garcia-Roca R;Tzvetanov I;Heitman A;Davis M;McGarrigle JJ;Benedetti E;Oberholzer J
本报告总结了在伊利诺伊大学芝加哥分校（UIC）进行的为期5年的1/2期同种异体胰岛移植临床试验。10例患者入组了这项单中心、开放标签和前瞻性试验，其中患者接受了1-3次移植。前4例受试者接受了埃德蒙顿免疫抑制方案的胰岛移植，其余6例受试者接受了UIC免疫抑制方案（埃德蒙顿加依那西普和依塞那肽）。所有10例患者在1-3次移植后均实现了胰岛素依赖性。在5年的随访中，最初的10名患者中有6名没有外源性胰岛素。在随访期间，10例患者中有7例维持阳性C肽水平，复合低血糖（HYPO）评分为0。大多数患者维持HbA 1c水平< 6.0%（42.1 mmol/mol），β评分显著改善。总之，这项研究证明了长期的胰岛移植功能，而不使用T细胞耗竭诱导，具有令人鼓舞的结果，包括60%的患者在初次移植5年后保持胰岛素依赖性。
This report summarizes a 5-year phase 1/2 allogeneic islet transplantation clinical trial conducted at the University of Illinois at Chicago (UIC). Ten patients were enrolled in this single center, open label, and prospective trial in which patients received 1–3 transplants. The first four subjects underwent islet transplantation with the Edmonton immunosuppressive regimen and the remaining six subjects received the UIC immunosuppressive protocol (Edmonton plus etanercept and exenatide). All 10 patients achieved insulin independence after 1–3 transplants. At five years of follow-up, six of the initial 10 patients were free of exogenous insulin. During the follow-up period, 7 of the 10 patients maintained positive C-peptide levels and a composite hypoglycemic (HYPO) score of 0. Most patients maintained HbA1c levels < 6.0% (42.1 mmol/mol) and a significantly improved β-score. In conclusion, this study demonstrated long-term islet graft function without using T-cell depleting induction, with an encouraging outcome that includes 60% of patients remaining insulin independent after five years of initial transplantation.