The research group led by Associate Professor Hirofumi Suemori of the Institute for Frontier Medical Sciences, Kyoto University has succeeded in establishing a clinical human ES cell line at a cell processing facility established in the field of embryonic stem cells at the same place for the first time in Japan.It is expected that the safety and effectiveness of regenerative medicine will be improved.
Pluripotent stem cells such as ES cells (embryonic stem cells) and iPS cells (induced pluripotent stem cells) have the ability to differentiate into all somatic cells, and are applied to regenerative medicine, pathological elucidation, drug discovery, etc. Is expected. Clinical studies have already been conducted on iPS cells in Japan, and clinical trials on ES cells have begun overseas.
Since it is necessary to establish a human ES cell line that can be used clinically in Japan, the Institute for Frontier Life and Regeneration will establish a cell processing facility (CPF) dedicated to human ES cells, establish a quality control system, and animals. Technological development of a culture system excluding derived components was promoted.
On January 2017, 1, this facility obtained permission to manufacture specific cell processed products as a clinical culture facility based on the Act on Ensuring Safety of Regenerative Medicine.On June 24, 2017, the Minister of Education, Culture, Sports, Science and Technology and the Minister of Health, Labor and Welfare confirmed the compliance with the guidelines for the establishment of human ES cell lines and the stock preparation plan for the first time in Japan.
This time, the research group succeeded in establishing a clinical human ES cell line, and submitted and accepted the establishment report to the Minister of Education, Culture, Sports, Science and Technology and the Minister of Health, Labor and Welfare.As a result, the establishment of a clinical human ES cell line has been officially achieved.The stock produced at this facility will be distributed to the National Center for Child Health and Development, etc., and will be used for research aimed at clinical application.
In cell transplantation medicine using pluripotent stem cells, it is expected that by proceeding with comparative studies using ES cell lines for humans as a new option in addition to iPS cells, it will contribute to improving the safety and effectiveness of regenerative medicine. Will be done.
