Human germline engineering

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Human germline engineering (HGE) is the process by which the genome of an individual is modified in such a way that the change is heritable. This is achieved by altering the genes of the germ cells, which mature into eggs and sperm. For safety, ethical, and social reasons, the scientific community and the public have concluded that germline editing for reproduction is inappropriate.^[1][2] HGE is prohibited by law in more than 70 countries^[3] and by a binding international treaty of the Council of Europe.

In November 2015, a group of Chinese researchers used CRISPR/Cas9 to edit single-celled, non-viable embryos to assess its effectiveness. This attempt was unsuccessful; only a small fraction of the embryos successfully incorporated the 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, a similar study was performed in China on non-viable embryos with extra sets of chromosomes. This study showed similar results to the first; except that no embryos adopted the desired gene.

In November 2018, researcher He Jiankui created the first human babies from genetically edited embryos, known by their pseudonyms, Lulu and Nana. In May 2019, lawyers in China reported that regulations had been drafted that anyone manipulating the human genome would be held responsible for any related adverse consequences.^[4]