The way to clinical application of human pluripotent stem cells

Abstract

Human embryonic stem (ES) cells are expected to be a resource 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 by introducing small sets of transcription factors, raising further hopes of clinical applications of pluripotent stem cells. Today, several promising projects using these cells have been launched. It is necessary to consider regulatory issues regarding iPS/ES cell applications from at least three points of view. First, researchers should pay serious attention to the rights of donors, particularly privacy prot ction and decision-making in terms of the use of pluripotent stem cells derived from “the pieces of their own body.” Second, for iPS/ES cell-based transplantation therapy, patients with target diseases should be protected from the risks of undergoing and not undergoing such treatments. Third, the dignity of life should be carefully considered. In Japan, there used to be two regulatory frameworks for the clinical application of pluripotent stem cells with respect to clinical studies: the provisions of the Pharmaceutical Affairs Law and Medical Practitioners’ Act. Recently, relevant regulatory reforms were made to promote and more rationally regulate the fi eld of regenerative medicine. In order to expedite the realization of clinical applications of pluripotent stem cells, researchers must follow established guidelines as well as precisely grasp the current trends in corresponding regulations and technologies.