| セッション情報 | International Session2(肝臓学会・消化器病学会合同)Gene therapy and cell therapy through the liver; current aspects and future prospects |
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| タイトル | 肝IS2-8指：The Way to Clinical Applications of human Pluripotent Stem Cells |
| 演者 | T. Aoi（Division of iPS cell Applications, Department of Internal Medicine, Kobe University） |
| 共同演者 | |
| 抄録 | Human embryonic stem (ES) cells have been expected as resources for regenerative medicine because of their pluripotency and ability to self-renew. In 2007, human induced pluripotent stem (iPS) cells were generated from somatic cells, raising further hopes of clinical applications of pluripotent stem cells. Today, several promising projects using them have already been launched. Now we must consider regulatory issues on the iPS/ES cells applications from, at least, three points of view. First, we should pay serious attention to the donors' rights of their privacy protection and decision-making about uses of the derivatives of "the pieces of their own body". Second, the patients with target diseases should be protected from the risks of undergoing the treatment as well as those of not undergoing the treatment. Third, dignity of life should be carefully considered. We, in Japan, have two regulatory frameworks for clinical application of the pluripotent stem cells: clinical studies carried out under the provisions of the Pharmaceutical Affairs Law and the Medical Practitioners Law. Recently, some new guidelines relating them came in force, and some are still on revising. For expediting realization of clinical applications of pluripotent stem cells, we must not only follow the established guidelines, but also precisely grasp the trend of corresponding regulation and technologies in comparison with other advanced medicinal products such as somatic cell therapy and gene therapy. |
| 索引用語 | iPS cell, clinical application |