U.K. gives scientists research to modify human embryos

Scientists investigating miscarriage will not be able to implant embryos or study them for more than two weeks, says HFEA.

Gene editing has just been given the green light in the United Kingdom — making the murky waters of genetic engineering all the more turbulent.

On Monday, the Human Fertilisation and Embryology Authority made the U.K. the first jurisdiction in the world to approve the controversial practice of altering the DNA of embryos, although it should be noted that these embryos are not to be implanted in women (no designer babies … yet). Rather, the purpose of the research to be carried out at the Francis Crick Institute seeks to better understand the importance of genes in the earliest stages of human development.

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.

The decision was hailed by the Francis Crick Institute and British scientists but will be met with disquiet by those concerned that rapid advances in the field of genome editing is precluding proper consideration of the ethical implications.

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.

The proposed experiments will begin in the first week following the fertilization of an ovum, during which a 200- to 300-cell structure known as a blastocyst is formed. This tiny ball of cells is a critical point in human development — only 50 percent of fertilized eggs ever became blastocysts, and only half of these implant into the womb, with only another half developing past the three-month period. This means that of every 100 fertilized eggs, a mere 13 survive the first 90 days or so.

Dr. Kathy Niakan, who will be conducting much of the research, spoke to the BBC about the importance of the newly approved work. “We would really like to understand the genes needed for a human embryo to develop successfully into a healthy baby,” she said. “The reason why it is so important is because miscarriages and infertility are extremely common, but they’re not very well understood.”

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.

The US National Institutes of Health will not fund any genome editing research on human embryos at present.

And while some skeptics are critical of the implications of gene modification, others insist that this work will be crucial to human health.

“I promise you [Dr. Niakan] has no intention of the embryos ever being put back into a woman for development,” Robin Lovell-Badge, group leader at the Crick Institute, told TIME. “That wouldn’t be the point. The point is to understand things about basic human biology. We know lots about how the early mouse embryo develops in terms of how various cell lineages give rise to the embryo or to [other] tissue that make up the placenta. But we know very little about how this happens in the human embryo.”

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