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https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/

<https://www.technologyreview.com/topic/rewriting-life/>Rewriting Life


EXCLUSIVE: Chinese scientists are creating CRISPR babies



A daring effort is under way to create the first 
children whose DNA has been tailored using gene editing.

    * by 
<https://www.technologyreview.com/profile/antonio-regalado/>Antonio Regalado
    * November 25, 2018
When Chinese researchers first edited the genes 
of a human embryo in a lab dish in 2015, it 
sparked global outcry and pleas from scientists 
not to make a baby using the technology, at least for the present.

It was the invention of a powerful gene-editing 
tool, CRISPR, which is cheap and easy to deploy, 
that made the birth of humans genetically 
modified in an in vitro fertilization (IVF) 
center a 
<https://www.technologyreview.com/s/535661/engineering-the-perfect-baby/>theoretical 
possibility.

Now, it appears it may already be happening.

According to Chinese medical documents posted 
online this month 
(<http://www.chictr.org.cn/showprojen.aspx?proj=32758>here 
and 
<http://www.chictr.org.cn/uploads/file/201811/bb9c5996d8fd476eacb4aeecf5fd2a01.pdf>here), 
a team at the Southern University of Science and 
Technology, in Shenzhen, has been recruiting 
couples in an effort to create the first 
gene-edited babies. They planned to eliminate a 
gene called CCR5 in hopes of rendering the 
offspring resistant to HIV, smallpox, and cholera.
Photo of Jiankui He
  He Jiankui leads a team using the gene-editing 
technology CRISPR in an effort to prevent disease in newborns.
Southern University of Science and Technology

The clinical trial documents describe a study in 
which CRISPR is employed to modify human embryos 
before they are transferred into women’s uteruses.

The scientist behind the effort, He Jiankui, did 
not reply to a list of questions about whether 
the undertaking had produced a live birth. 
Reached by telephone, he declined to comment.

However, data submitted as part of the trial 
listing shows that genetic tests have been 
carried out on fetuses as late as 24 weeks, or 
six months. It’s not known if those pregnancies 
were terminated, carried to term, or are ongoing.

[After this story was published, the 
<https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d>Associated 
Press reported that according to He, one couple 
in the trial gave birth to twin girls this month, 
though the agency wasn't able to confirm his 
claim independently. He also released a 
<https://www.youtube.com/watch?v=th0vnOmFltc>promotional 
video about his project.]

The birth of the first genetically tailored 
humans would be a stunning medical achievement, 
for both He and China. But it will prove 
controversial, too. Where some see a new form of 
medicine that eliminates genetic disease, others 
see a slippery slope to enhancements, designer 
babies, and a new form of eugenics.

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 “<http://www.1000plan.org/en/>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 
<https://twitter.com/theNASEM/status/1060582875509243904>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 editing­a 
powerful and useful technique­was 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 
<https://www.youtube.com/watch?v=llxNRGMxyCc>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 
<http://www.directgenomics.com/>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.

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 
<http://www.chictr.org.cn/showprojen.aspx?proj=32758>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 
<https://www.technologyreview.com/s/603633/us-panel-endorses-designer-babies-to-avoid-serious-disease/>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.

Public opinion

In recent weeks, He has begun an active outreach 
campaign, speaking to ethics advisors, 
commissioning an opinion poll in China, and 
hiring an American public-relations professional, Ryan Ferrell.

“My sense is that the groundwork for future 
self-justification is getting laid,” says 
Benjamin Hurlbut, a bioethicist from Arizona 
State University who will attend the Hong Kong summit.

The new 
<http://www.globaltimes.cn/pdf/ChinesePublicAttitudesOnGeneEditing2018.11.12.pdf>opinion 
poll, which was carried out by Sun Yat-Sen 
University, found wide support for gene editing 
among the sampled 4,700 Chinese, including a 
group of respondents who were HIV positive. More 
than 60% favored legalizing edited children if 
the objective was to treat or prevent disease. 
(Polls by the 
<http://www.pewinternet.org/2018/07/26/public-views-of-gene-editing-for-babies-depend-on-how-it-would-be-used/>Pew 
Research Center have found similar levels support in the US for gene editing.)

He’s choice to edit the gene called CCR5 could 
prove controversial as well. People without 
working copies of the gene are believed to be 
immune or highly resistant to infection by HIV. 
In order to mimic the same result in embryos, 
however, He’s team has been using CRISPR to 
mutate otherwise normal embryos to damage the CCR5 gene.

The attempt to create children protected from HIV 
also falls into an ethical gray zone between 
treatment and enhancement. That is because the 
procedure does not appear to cure any disease or 
disorder in the embryo, but instead attempts to 
create a health advantage, much as a vaccine protects against chicken pox.

For the HIV study, doctors and AIDS groups 
recruited Chinese couples in which the man was 
HIV positive. The infection has been a growing problem in China.

So far, experts have mostly agreed that gene 
editing shouldn’t be used to make “designer 
babies” whose physical looks or personality has been changed.

He appeared to anticipate the concerns his study 
could provoke. “I support gene editing for the 
treatment and prevention of disease,” He posted 
in November to the social media site WeChat, “but 
not for enhancement or improving I.Q., which is not beneficial to society.”

Still, removing the CCR5 gene to create HIV 
resistance may not present a particularly strong 
reason to alter a baby’s heredity. There are 
easier, less expensive ways to prevent HIV 
infection. Also, editing embryos during an IVF 
procedure would be costly, high-tech, and likely 
to remain inaccessible in many poor regions of the world where HIV is rampant.

A person who knows He said his scientific 
ambitions appear to be in line with prevailing 
social attitudes in China, including the idea 
that the larger communal good transcends 
individual ethics and even international guidelines.

Behind the Chinese trial also lies some bold 
thinking about how evolution can be shaped by 
science. While the natural mutation that disables 
CCR5 is relatively common in parts of Northern 
Europe, it is not found in China. The 
distribution of the genetic trait around the 
world­in some populations but not in 
others­highlights how genetic engineering might 
be used to pick the most useful inventions 
discovered by evolution over the eons in 
different locations and bring them together in tomorrow’s children.

Such thinking could, in the future, yield people 
who have only the luckiest genes and never suffer 
Alzheimer’s, heart disease, or certain infections.

<http://www.sustc-genome.org.cn/>The text of an 
academic website that He maintains shows that he 
sees the technology in the same historic, and 
transformative, terms. “For billions of years, 
life progressed according to Darwin’s theory of 
evolution,” it states. More recently, 
industrialization has changed the environment in 
radical ways posing a “great challenge” that 
humanity can meet with “powerful tools to control evolution.”

It concludes: “By correcting the disease genes … 
we human[s] can better live in the fast-changing environment.”

Note: This story was updated after publication to 
include claims by He Jiankui that the trial had produced live births.

-----------------------------
<https://www.technologyreview.com/profile/antonio-regalado/>Antonio 
Regalado Senior Editor, Biomedicine

I am the senior editor for biomedicine for MIT 
Technology Review. I look for stories about how 
technology is changing medicine and biomedical 
research. Before joining MIT Technology Review in 
July 2011, I lived in São Paulo, Brazil, where I 
wrote about science, technology, and politics in 
Latin America for Science and other publications. 
 From 2000 to 2009, I was the science reporter at 
the Wall Street Journal and later a foreign correspondent.