Japan's Ministry of Health, Labour and Welfare has recently formulated a set of safety standards for the clinical application of stem cells, requiring a series of safety reviews of induced pluripotent stem cells (iPS cells) and embryonic stem cells used in clinical treatment and research.
Under Japan's "Act on the Safety of Regenerative Medicine", which took effect in 2014, treatment and research using iPS cells and embryonic stem cells were classified as the highest-risk "Class I", and researchers must undergo review by a dedicated committee when carrying out related treatment and research. However, in the absence of specific standards on the safety of these stem cells, reviews could become inconsistent.
According to the newly formulated safety standards, when using iPS cells and the like to culture cells for transplantation, researchers must investigate the chromosome number and morphology of the differentiated cells, as well as whether more than 600 genes related to carcinogenesis are abnormal; before human transplantation, animal experiments must also be conducted to confirm whether the cells carry a risk of carcinogenesis.
Stem cell research is highly anticipated in the field of regenerative medicine, but safety has also become an increasingly hot topic in the field. Take iPS cells as an example: these cells can be differentiated into specific cell types and used for transplantation therapy, but if undifferentiated iPS cells are transplanted, or if the iPS cells themselves carry genetic abnormalities, the transplanted cells will carry a risk of carcinogenesis.
