A. Please refer to the risk classification (see diagram below) provided by the Ministry of Health, Labour and Welfare (click to enlarge). If you are unsure, please contact the relevant Health Bureau or this committee. Our organization is capable of reviewing all cases of Type 1, 2, and 3.
※ Regarding “homologous use,” this refers to the administration method of cells with similar functions to cells in the target area for regenerative medical treatment. For example, if adipose cells are harvested from the abdomen and adipose tissue-derived stem cells are isolated from those cells, and then administered to the site of breast cancer surgery for breast reconstruction purposes, this qualifies as homologous use. However, administering adipose tissue-derived stem cells intravenously for the purpose of treating diabetes does not qualify as homologous use because it is not for the reconstruction of adipose tissue. Additionally, regarding medical techniques using peripheral blood without centrifugation and cultivation, for example, administration to the skin or oral cavity qualifies as homologous use, but administration to tissues with poor blood flow such as joint cavities does not qualify as homologous use. (Excerpt from Director’s Notice No. 1031 dated October 31, 2014, from the Health Policy Bureau)
