The Ministry of Health, Labor and Welfare of Japan has recently formulated a safety standard for the clinical application of stem cells, requiring a series of safety reviews for induced pluripotent stem cells (iPS cells) and embryonic stem cells for clinical treatment and research.
In Japan’s “Regenerative Medicine Safety Assurance Act” implemented in 2014, iPS cell and embryonic stem cell treatment and research are classified as the highest risk “Category 1”. When implementing related treatments and research, researchers need to undergo review by a specialized committee. But without specific standards on the safety of these stem cells, scrutiny can be confusing.
According to the latest safety standards, when using iPS cells to culture cells for transplantation, researchers need to investigate the chromosome number and morphology of differentiated cells, as well as the 600 Whether multiple genes are abnormal; before human transplantation, animal experiments must be carried out to confirm whether the cells have the risk of becoming cancerous.
Stem cell research is highly anticipated in the field of regenerative medicine, but safety issues have increasingly become a hot topic in this field. Take iPS cells as an example. These cells can be used for transplantation treatment after being differentiated into specific cells. However, if undifferentiated iPS cells are transplanted, or iPSThe cells themselves have genetic abnormalities, so the transplanted cells will be at risk of becoming cancerous.