Nature asked researchers and other stakeholders what hurdles remain before heritable gene editing could become acceptable as a clinical tool. Although some scientific challenges are probably surmountable, approval on a grand scale is likely to require changes to how clinical trials are run, as well as a broader consensus about the technology .
Even if the targeting and precision of changes in genome editing were perfect, there would still be a question about what kinds of changes to the human germ line are likely to be safe. In 2017, an international effort spearheaded by the US National Academies of Sciences, Engineering, and Medicine outlined the conditions that should be met before editing a human embryo that is destined for implantation. One of the criteria was that the DNA sequence created by the edit already be common in the population, and carry no known risk of disease.
That requirement alone would put heritable gene editing in people out of reach for the near future, says Porteus. It is not only difficult to predict the precise sequence of an edit, but also hard to know with certainty that a variant will not increase the risk of disease.
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