An overview of "the guideline for clinical research using human stem cells"

A medical system is anticipated, where high-quality medical services are accessible without anxieties whenever we are ill or injured. The innovative regenerative medical products have enabled us to overcome some life threatening diseases, however, challenges still remain for others. The Ministry of Health, Labour and Welfare has implemented "The guideline for clinical research using human stem cells" and has launched on Sept 1, 2006. The major goal of the guideline is to reinforce and ensure safe on investigational new regenerative medical products. In this paper, I will give an overview of the guideline for clinical research using human stem cells, which intends to satisfy unmet medical needs in the field of regenerative medicine as well as to keep medical advances in Japan.