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First CRISPR babies: 6 issues left

Zhou Xiaoqin (l) transmits Cas9 protein and PCSK9 sgRNA molecule into a fine glass pipette as Qin Jinzhou clocks.

The CRISPR-Cas9 gene edit tool is loaded into the pipette. Credit: Mark Schiefelbein / AP / Shutterstock

The meeting at which Jiankui explained his outstanding claim to assist in the production of the first babies – twins – born with decorated genomes, ended with a statement dropping scientist.

"We have heard the unexpected and deeply disturbing claims that human embryos were edited and embedded, resulting in pregnancy and twins being born," said the organizing committee of the 2nd International Human Development Gathering Summit in Hong Kong on November 29. "Even if the changes were verified, the procedure was irresponsible and did not conform to international standards."

Similar criticism came from the discovery earlier this week that CRISPR-Cas9 used to modify the CCR5 gene in two embryos, which was then embedded in a woman. Gen encodes the protein that many strains of HIV use to infect immune cells, into two embryos, then embedded in a woman.

As researchers exchange weekly events, Nature summarizes six major issues that have not yet been answered.

1. Is Jiankui in distress?

On November 27, the Chinese national health ministry invited the Guangdong government – where its university, the South University of Science and Technology – to explore. Two days later, the Ministry of Science instructed him to stop working any science; He has already said that experiments are pending. How the Guangdong investigation will start is not clear. He is charged with a violation of the Ministry of Health guidelines for 2003, which is no law and no clear punishment.

Whether the university, the South University of Science and Technology, is taking any action against it, is also unclear. A university spokeswoman said Nature that at this time "can not disclose such information" and wait for official statements "at a suitable time". He has been absent since February 2018, and will last until January 2021; this week, the university has criticized its claims and distanced itself from its work.

On November 27, a laboratory website led by a university – to whom people were sent to information about genetically-engineered babies – dropped, although there was still room for his lab. Several statements that praise his Jiankui success have also disappeared from government venues. On the official page of the Ministry of Science that describes the genomic sequenced technology it has developed, and the post praising its genomic sequenced technology on the Thousand Talents Plan website – a prestigious scheme to lead leading scientists back to China – are now unavailable. It's not clear whether this action is related to events in the week, but both posts were available until recently.

He returned to Shenzhen, where he lives, following a summit debate, according to a statement spoken by his spokesman Ryan Ferrell and missed the planned performance at the November 29 summit. "I returned to Shenzhen and will not attend a conference on Thursday, I will stay in China, my homeland and fully cooperate with all my business issues," the statement said.

2. Are the Claims Correct?

Many scientists have said that an independent body should confirm He's scientific assertions by performing a deeper comparison of genomes of parents and children. The problem is that most agree that babies and their parents should remain anonymous.

"He kept them secret, and for good reasons," says Nobel laureate David Baltimore, chair of the Summit Organizing Committee and former president of the California Institute of Technology in Pasadena. "We did not even even say that this independent investigation would happen."

The team could supply anonymous samples. External scientists can also visit He's a data analysis lab. In a statement released by his spokesman, he said he would invite other investigators to conduct an independent investigation. "My raw data will be available for third party views."

He also says he has submitted studies on his human gene research in the journals for publication. He told some scientists that the paper would be published by the end of the year but did not specify which magazine. But even if this happens, the strict laws of Chinese genetic resources prevent it from publishing genetic sequences of parents or children.

3. How exactly does CRISPR regulate genomic twins?

In the absence of a reviewed publication or a preface describing He's gen-editing work, some scholars split their presentation to try to figure out how the twin genomes are edited – and all the potential consequences of these changes.

Gaetan Burgio, a geneticist at the National University of Australia in Canberra who works on regulating CRISPR genes, says the crude sequencing information that he put forward in his speech suggests that baby cells have more decorated versions of the CCR5 gene with different sizes of DNA deletions. Such "mosaicism" can be caused when CRISPR regulates an earlier incident cell differently or does not change some. Other researchers reported a mosaic in human embryo research efforts for research purposes.

RNA researcher Sean Ryder, at the Massachusetts University of Medicine at Worcester, noted additional concern in Twitter post.

He told Jiankui a genealogy conference to direct the CCR5 gene because some people, of course, carry a mutation in the CCR5 – 32 DNA deletion known as delta-32 – which inactivates the gene. But Ryder says the CCR5 deletions claimed to be introduced into baby cells by CRISPR gene are not identical to the delta-32 mutation. "It's important that none of the three responds well to the well-studied delta 32 mutations, and as I say, no one has been studied in animal models. Unofficial," Ryder wrote in the post.

Jiankui, sitting, looks to answer questions during his presentation on the humanistic arrangement of the summit on November 28

Jiankui claims to have helped in the production of the first babies born with modified genomes.Credit: TPG via Zume

4. When will there be another gene-modified man?

As Jennifer Doudna, the pioneer of the CRISPR / Cas-9 genetic engineering tool, listened to the presentation of her work on November 28 in the summer, one of her ideas came back. "The thought I kept was the potential of scientists to use it in an unethical way. That's a real risk," says Doudna, a biochemist at the University of California, Berkeley,

Prior to the discovery, many scientists were already concerned about the possibility that someone was on the verge of creating a genetically-engineered person. Biologist George Daley, dean of the Harvard Medical School in Boston, Massachusetts, and a member of the committee for organizing the summit, pointed out a procedure that replaces sick mitochondrial DNA in the embryo with a healthy mitochondrial DNA to another person, removing the primary causes of mutation mutation disease. Although mitochondrial replacement therapy does not have the approval of a biomedical community or the US Food and Drug Administration (FDA), New York-based physicians used it to produce a baby in Mexico in 2016. "The similarly embedded embryo processing practice by CRISPR / Cas9 is unlikely despite our calls for caution," said Daley.

At a summit in Hong Kong, scientists were discussing whether any other notice about the regulation of human germline – gene change has been transferred to future generations – is near. "We have reason to worry," Baltimore said. "If someone who works on the ground gets the indication that this is happening, it's important to let the authorities know."

5. Will its discovery prevent ethical efforts to redesign?

Many researchers are afraid of those discoveries that could hinder the future of brooding. "In the US some suggest draconian bans, which is contradictory to the goals of science," says Baltimore.

In the light of the discovery, FDA commissioner Scott Gottlieb has outlined comments that caused concern among scientists. "The government will now have to react," he told the Biocentury newspaper page. And on November 28, the director of the United States National Institute for Health (NIH), Francis Collins, said in a statement that "the need to develop a binding international consensus on imposing restrictions on this type of research that has been discussed in Hong Kong has never been more visible."

The statement released at the very top invites an open route to the safe translation of genetic engineering technology into treatments: "The design of the German genome may become acceptable in the future if those risks are solved."

But debacle has focused on the global interest for generational generations, and fears of cooling can be overstated. "Some women might be excited about the possibility of participating in this research," said Judith Dar at the Medical School and the University of California Law at a summit satellite meeting when asked whether controversy might distract women from donating research eggs in the future . "The instinct is to say that this is a weakness and can prevent participation, but I'm always interested in various reactions," she added.

6. How will scientists provide better control over "germline" editing in the future?

"We do not have a blueprint, but we set up the academy," Baltimore said. "It's a challenge for the world."

The statement issued by the Summit Committee suggests that scientific academies all over the world give recommendations to their authorities, coordinating each other.

It is also proposed to create an international forum that will conduct research and clinical trials through the international registry and discuss issues such as fair access to the benefits of genetic editing. However, genetic modification in human embryos potentially has an uncomfortable range of users and this could make it more difficult to maintain such an organization. "Almost every molecular biology lab uses this technique," Daley said.

The committee also suggested the need for "translation" that would provide a rigorous and responsible way for researchers to transfer gene genetic modification to the clinic. A member of the organizing committee of Alta Charo, a bioethicist at the University of Wisconsin-Madison, said expectations must be realistic. "You can not expect perfection. What you can do is try to minimize these incidents with executions that punish rogue behavior."

The next human genome editing summit will be held in London in 2021.

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