The estab lishmentt of Hiroshima human hepatocyte bank

日本肝细胞在新药开发的研究中是非常重要的，因为不仅动物之间，人类之间的药物代谢也存在差异。然而，还有许多问题需要讨论，如个人信息保护和生命伦理。1998年，我们开始了从非病毒性转移性肝肿瘤患者的切除肝脏中分离的人肝细胞的研究，目标是生物人工肝支持系统和肝细胞移植等再生医学。我们建立了人肝细胞灌注、冷冻保存和培养体系。在此背景下，我们强烈确定建立公共人类肝细胞库用于研究的必要性。我们采纳了三个重要的计划。首先是引入两步知情同意，即所有患者首次来我院时的全面同意和手术前对细胞库的二次同意。第二是病理学家的参与，他们判断肝脏组织捐赠是否充分和安全。三是雇用临床研究协调员（CRC），他们可以支持患者的精神护理（捐赠者），协助研究人员，并将研究成果回报社会。我们将7例日本人肝细胞提供给公共资源库用于研究。

Japanese hepatocytes are strongly required for research on development of a new medicine, because there are differences in drug metabolism among not only animal species but also human races. However there are many issues to be discussed such as protection of personal information and bioethics. In 1998, we started research on human hepatocytes isolated from a resected liver of patients with non-viral metastatic liver tumor aiming at regenerative medicine such as bioartificial liver support system and hepatocyte transplantation. We have established perfusion, cryopreservation, and cultivation system of human hepatocytes. On the basis of the background, we are strongly certain about the necessity of a public human hepatocyte bank for research use. We adopted three important plans. The first is the introduction of two step-informed consent which consists of the comprehensive consent for all patients when they first visit our hospital and the secondary consent for cell bank before the operation. The second is the participation of pathologists who judge if the liver tissue was adequately and safely donated or not. The third is the employment of CRC (clinical research coordinators) who can support mental care of patients (donors), assist researchers and return the research results to society. We provided 7 cases of Japanese human hepatocytes to the public resource bank for research use.