Human germline engineering

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Human germline engineering is the process by which the genome of an individual is edited in such a way that the change is heritable. This is achieved by altering the genes of the germ cells, which then mature into genetically modified eggs and sperm. For safety, ethical, and social reasons, there is broad agreement among the scientific community and the public that germline editing for reproduction is a red line that should not be crossed at this point in time. There are differing public sentiments, however, on whether it may be performed in the future depending on whether the intent would be therapeutic or non-therapeutic.^[1][2]

Using germline editing for reproduction is prohibited by law in more than 70 countries^[3] and by a binding international treaty of the Council of Europe. However, in November 2015, a group of Chinese scientists used the gene-editing technique CRISPR/Cas9 to edit single-celled, non-viable embryos to see the effectiveness of this technique. This attempt was rather unsuccessful; only a small fraction of the embryos successfully incorporated the new genetic material and many of the embryos contained a large number of random mutations. The non-viable embryos that were used contained an extra set of chromosomes, which may have been problematic. In 2016, another similar study was performed in China which also used non-viable embryos with extra sets of chromosomes. This study showed very similar results to the first; but there weren't successful integrations of the desired gene, and the majority of the attempts failed, or produced undesirable mutations.

In November 2018, researcher He Jiankui created the first human genetically edited babies, known by their pseudonyms, Lulu and Nana. In May 2019, lawyers in China reported, in light of the purported creation by He Jiankui of the first gene-edited humans, the drafting of regulations that anyone manipulating the human genome by gene-editing techniques, like CRISPR, would be held responsible for any related adverse consequences.^[4]