Scientists investigating miscarriage will not be able to implant embryos or study them for more than two weeks, says HFEABritain’s first genetically modified human embryos could be created within months, after scientists were granted permission by the fertility regulator to carry out the procedure.
The Human Fertilisation and Embryology Authority (HFEA) regulator approved a licence application by Kathy Niakan, a stem cell scientist at the Francis Crick Institute in London, to perform so-called genome editing on human embryos.
The decision permits Niakan to study the embryos for 14 days for research purposes only. It does not permit them to be implanted into women. Niakan’s research is aimed at finding the genes at play in the early days of human fertilisation.
Paul Nurse, director of the institute, said: “I am delighted that the HFEA has approved Dr Niakan’s application. Dr Niakan’s proposed research is important for understanding how a healthy human embryo develops and will enhance our understanding of IVF success rates, by looking at the very earliest stage of human development – one to seven days.”
The work, using embryos donated by couples with a surplus after IVF treatment, will look at the fertilised egg’s development from a single cell to around 250 cells. The basic research could help scientists understand why some women lose their babies before term and provide better clinical treatments for infertility, using conventional medical methods.
Niakan will use a powerful genome editing procedure called Crispr-Cas9 to switch genes on and off in early stage human embryos. She will then look for the effects the modifications have on the development of the cells that go on to form the placenta.
Crispr-Cas9 has revolutionised biomedical research since its invention three years ago. It allows scientists to make precise changes to DNA, and has the potential to transform the treatment of genetic disorders by correcting faulty genes.
Prof Robin Lovell-Badge, group leader at the Francis Crick Institute, said: “I am delighted for my colleague Kathy Niakan that the HFEA has approved her licence application. This will allow her to not only continue her research on how the early human embryo develops, but allow her to address the role of specific genes through the use of CRISPR/Ca9 genome editing methods. The approval of her licence gives the exciting prospect that we will at last begin to understand how the different cell types are specified at these pre-implantation stages in the human embryo.”
Lovell-Badge said it would also provide invaluable information about the accuracy and efficiency of the technique, helping to inform the debate about whether genome editing could be used in future to correct faulty genes that cause devastating diseases.
That prospect remains a long way off but is already a subject of concern. There are also fears that changes to an embryo’s DNA could have unknown harmful consequences throughout a person’s body and be passed on down the generations.
Last year, leading UK funders called for a national debate on whether editing human embryos could ever be justified in the clinic. Some fear that a public backlash could derail less controversial uses of genome editing, which could lead to radical new treatments for disease.
But supporters of the HFEA’s decision said it had arrived at the right conclusion, balancing the benefits to research and ethical considerations.
“The ruling by the HFEA is a triumph for common sense,” said Darren Griffin, a professor of genetics at the University of Kent. “While it is certain that the prospect of gene editing in human embryos raised a series of ethical issues and challenges, the problem has been dealt with in a balanced manner. It is clear that the potential benefits of the work proposed far outweigh the foreseen risks.”
Sarah Norcross, director of Progress Educational Trust, called it “a victory for level-headed regulation over moral panic”.
Dr Sarah Chan, chancellor’s fellow at Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, said: “We should feel confident that our regulatory system in this area is functioning well to keep science aligned with social interests.”
