World first: license to edit human embryonic cells for fertility research in UK approved

UK scientists have been granted permission by the UK Human Fertilisation and Embryology Authority (HFEA) to genetically modify human embryos, the first national regulatory authority in the world to approve such research. Dr Kathy Niakan, at the Francis Crick Institute in London, applied last year, and was granted the license to edit embryonic genomes, a controversial procedure, to investigate early human development on the 1^st February 2016. This follows a Chinese group who last year reported using a similar method in non-viable human embryos to investigate the plausibility of modifying the gene responsible for a disease, β-thalassaemia, as a potential genetic therapy.

The license permits genetic editing of human embryos, donated with consent by couples undergoing IVF who had surplus healthy embryos, to explore the role of certain genes active in very early development. Niakan’s study will benefit from the relatively recent CRISPR–Cas9 technique which can facilitate precise modification, removal and insertion of specific genes, with high efficiency, and which has been used widely in research already. It will be used to block a gene called OCT4, a master regulator gene which is active in cells that eventually form the foetus and implicated in embryonic development in mice, in up to 30 embryos initially. The development of these embryos will then be monitored.

While these experiments could aid development of future treatments for infertility and miscarriage, this license is not for gene therapy but for research, and accordingly there are limitations. Experimentation will stop after 7 days when the blastocysts, by then made up of up to 256 cells will be destroyed, and strict regulations still make it illegal for any edited embryo to be implanted into women.

HFEA described it as “a justified technical approach”, although there are many ethical issues and challenges raised by genetic manipulation of human embryos. There is some opposition from groups such as Comment on Reproductive Ethics, and a number of scientists, campaigners and health experts who previously signed an open letter suggesting an irrevocable change to the human species might occur if edited embryos were to be implanted. However, this remains illegal, and the license is widely looked on as a positive move in the study of fertility.

This permit may encourage others to apply both in the UK and abroad to their own governing bodies. Robin Lovell-Badge, also at the Crick Institute, has already heard from other UK scientists keen to investigate developmental biology with embryo-editing and anticipates more applications will be submitted. In addition, Sarah Chan at the University of Edinburgh, a bioethicist, thinks “this will be a good example to countries who are considering their approach to regulating this technology”, particularly due to the distinction between embryo genetic modifications for research purposes rather than reproduction. Furthermore, a bioethicist in Japan, thinks this will also stimulate debates on the legal regulation of clinical gene editing of cells that can pass on genes to the next generation.

Photo: http://www.digitaltrends.com/cool-tech/gene-editing-uk/