Yamahara Kenichi
Division of Molecular and Cellular Medicine, Institute for Advanced Medical Sciences, Hyogo Medical University.
Rinsho Ketsueki. 2022;63(10):1440-1445. doi: 10.11406/rinketsu.63.1440.
This study focused on amnion-derived mesenchymal stem cells (MSCs), which have immune- and inflammation-regulating properties, 1) a large number of stem cells, 2) high proliferative potential, and 3) are non-invasive to harvest. Based on the general research reported in many immune- and inflammation-related disease models, research on their commercial and therapeutic application was conducted. We have successfully manufactured a clinical trial product of amnion MSCs for the first time worldwide (clinical trial product name: AM01) and conducted physician-led clinical trials for acute graft versus host disease and Crohn's disease. Furthermore, CTEX Corporation, the first certified venture from Hyogo College of Medicine, was launched to further accelerate the clinical trial progression to obtain the manufacturing and marketing approval for amnion MSC AM01 to be used as a regenerative medical product at early stage.
本研究聚焦于羊膜间充质干细胞（MSCs），其具有免疫调节和炎症调节特性，1）干细胞数量众多，2）增殖潜力高，3）获取时无创。基于许多免疫和炎症相关疾病模型的一般研究，开展了其商业和治疗应用的研究。我们首次在全球成功制造了羊膜间充质干细胞的临床试验产品（临床试验产品名称：AM01），并针对急性移植物抗宿主病和克罗恩病开展了由医生主导的临床试验。此外，作为兵库医科大学首个认证的风险企业，CTEX公司成立，以进一步加速临床试验进程，尽早获得羊膜间充质干细胞AM01作为再生医疗产品的生产和销售许可。
