The step toward genetically tailored humans was undertaken in secrecy and with the clear ambition of a stunning medical first.

“In this ever more competitive global pursuit of applications for gene editing, we hope to be a stand-out,” He and his team wrote in an ethics statement they submitted last year. They predicted their innovation “will surpass” the invention of in vitro fertilization, whose developer was awarded a Nobel Prize in 2010.

Gene-editing summit

The claim that China has already made genetically altered humans comes just as the world’s leading experts are jetting into Hong Kong for the Second International Summit on Human Genome Editing.

The purpose of the international meeting is to help determine whether humans should begin to genetically modify themselves, and if so, how. That purpose now appears to have been preempted by the actions of He, an elite biologist recruited back to China from the US as part of its “Thousand Talents Plan.”

The technology is ethically charged because changes to an embryo would be inherited by future generations and could eventually affect the entire gene pool. “We have never done anything that will change the genes of the human race, and we have never done anything that will have effects that will go on through the generations,” David Baltimore, a biologist and former president of the California Institute of Technology, who chairs the international summit proceedings, said in a pre-recorded message ahead of the event, which begins Tuesday, November 27.

It appears the organizers of the summit were also kept in the dark about He’s plans.

Regret and concern

The genetic editing of a speck-size human embryo carries significant risks, including the risks of introducing unwanted mutations or yielding a baby whose body is composed of some edited and some unedited cells. Data on the Chinese trial site indicate that one of the fetuses is a “mosaic” of cells that had been edited in different ways.

A gene-editing scientist, Fyodor Urnov, associate director of the Altius Institute for Biomedical Sciences, a nonprofit in Seattle, reviewed the Chinese documents and said that, while incomplete, they do show that “this effort aims to produce a human” with altered genes.

Urnov called the undertaking cause for “regret and concern over the fact that gene editing—a powerful and useful technique—was put to use in a setting where it was unnecessary.” Indeed, studies are already under way to edit the same gene in the bodies of adults with HIV. “It is a hard-to-explain foray into human germ-line genetic engineering that may overshadow in the mind of the public a decade of progress in gene editing of adults and children to treat existing disease,” he says.

Big project

In a scientific presentation in 2017 at Cold Spring Harbor Laboratory, which is posted to YouTube, He described a very large series of preliminary experiments on mice, monkeys, and more than 300 human embryos. One risk of CRISPR is that it can introduce accidental or “off target” mutations. But He claimed he found few or no unwanted changes in the test embryos.

He is also the chairman and founder of a DNA sequencing company called Direct Genomics. A new breed of biotech companies could ultimately reap a windfall should the new methods of conferring health benefits on children be widely employed.

The first International Summit on Human Gene Editing, held in December 2015 in Washington, DC. The second is taking place in Hong Kong on November 27-29, 2018. The National Academies of Science, Engineering and Medicine

According to the clinical trial plan, genetic measurements would be carried out on embryos and would continue during pregnancy to check on the status of the fetuses. During his 2017 presentation, He acknowledged that if the first CRISPR baby were unhealthy, it could prove a disaster.

“We should do this slow and cautious, since a single case of failure could kill the whole field,” he said.

A listing describing the study was posted in November, but other trial documents are dated as early as March of 2017. That was only a month after the National Academy of Sciences in the US gave guarded support for gene-edited babies, although only if they could be created safely and under strict oversight.

Currently, using a genetically engineered embryo to establish a pregnancy would be illegal in much of Europe and prohibited in the United States. It is also prohibited in China under a 2003 ministerial guidance to IVF clinics. It is not clear if He got special permission or disregarded the guidance, which may not have the force of law.