Quality control for clinical islet transplantation: organ procurement and preservation, the islet processing facility, isolation, and potency tests
Quality control for clinical islet transplantation: organ procurement and preservation, the islet processing facility, isolation, and potency tests
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DOI：
10.1007/s00534-009-0064-z
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发表时间：
2009-03-01
期刊：
影响因子：
--
通讯作者：
Miyakawa, Shuichi
中科院分区：
文献类型：
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作者：
Yamamoto, Toshiyuki;Horiguchi, Akihiko;Miyakawa, Shuichi
由于隔离技术和免疫抑制方案的改进，胰岛移植已成为1型糖尿病患者的理想治疗方法之一。为了确保患者的安全和权利，分离的胰岛需要同时满足生物制品和药品的监管标准。因此，为了移植的持续成功，所有参与临床胰岛移植的研究者必须努力确保临床胰岛分离和移植的所有阶段中胰岛的安全性、纯度和效力。本文就临床胰岛分离和移植的质量控制以及胰岛移植前评估的最新进展作一综述。
Pancreatic islet transplantation has become one of the ideal treatments for patients with type 1 diabetes mellitus due to improvements in isolation techniques and immunosuppression regimens. In order to ensure the safety and rights of patients, isolated islets need to meet the criteria for regulation as both a biological product and a drug product. For the constant success of transplantation, therefore, all investigators involved in clinical islet transplantation must strive to ensure the safety, purity, and potency of islets in all the phases of clinical islet isolation and transplantation. In this review, we summarize the quality control for clinical islet isolation and transplantation, and the latest topics of pre-transplant islet assessment.