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The world's first manufactured babies created in China, scientists claim – National

A Chinese researcher claims to have helped to become the world's first genetically-regulated baby – girls who were born this month whose DNA said it had changed with a powerful new tool capable of transcribing the life plan itself.

If it is true, it would be a great jump of science and ethics.

READ MORE: How Scientists Use Editing of Human Embryo Repair Gene

An American scientist said he was involved in work in China, but this type of genome regulation in the United States is banned because DNA changes can be passed on to future generations and risking harming other genes.

Many major scientists believe it is too unusual to try, and some have disclosed the Chinese report as human experimentation.

The researcher, He Jiankui from Shenzhen, said he had changed embryos for seven couples during fertility treatment, and so far there has been a single pregnancy. He said that his goal was to heal or prevent inherited diseases, but to try to give the characteristic that few naturally have – the ability to resist the possible future infection of HIV, the AIDS virus.

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He said that the involved parents refused to be identified or interviewed and that they would not say where they were living or where the job was done.

There is no independent confirmation of his claim, and is not published in the magazine, which would be confirmed by other experts. On Monday, he announced in Hong Kong one of the organizers of an international genetic editing conference to begin on Tuesday, and earlier in exclusive interviews with The Associated Press.

"I feel great responsibility that it is not just to make the first one but to make it an example," AP said. "The Society will decide what to do next" in the sense of permitting or prohibiting such a science.

Some scientists were surprised to hear about the claim and strongly condemn him.

READ MORE: Scientists change human embryo DNA, does this open the door for designer babies?

It is "unfounded … an experiment on human beings that is not morally or ethically defenseless," said Dr Kiran Musunuru, a genetic expert at the University of Pennsylvania and editor of a genetic journal.

"It's too early," said Dr. Eric Topol, who heads the Scripps Research Translational Institute in California. "We are dealing with instructions for the work of a human being. That's a big deal."

However, a well-known geneticist, the George Church of Harvard University, defended an attempt to genetically regulate HIV, which he called "a growing and growing public health danger".

"I think that is justified," said the Church for that goal.

In this photo of October 10, 2018, He Jiankui is reflected in a glass panel while working on a computer at a laboratory in Shenzhen, Guangdong province, in southern China.

AP Photo / Mark Schiefelbein

In the past few years, scientists have discovered a relatively simple way to edit genes, DNA samples that control the body. The tool, called CRISPR-cas9, allows you to work on DNA to provide the needed gene or disable the one that causes problems.

Recently, it has been tried in adults to treat deadly diseases, and changes are limited to that person. Editing sperm, eggs or embryos is different – changes can be inherited. In the United States, it is not allowed other than laboratory research. China prohibits cloning of people, but not specific genetic modification.

Jiankui, who runs "JK", studied at Rice and Stanford University in the United States before returning to his homeland to open a laboratory at the South China Science and Technology University in Shenzhen, where he also has two genetic companies.

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The American scientist who worked with him on this project after returning to China was professor of physics and bioengineering, Michael Deem, who was his advisor at Rice, Houston. Deem also holds what he called a "small bet" – and he is in scientific advisory boards – his two companies.

A Chinese researcher said he had been practicing editing mice, monkeys and human embryos in the laboratory for years and applied for patents by his methods.

He said he chose an embryonic gene for HIV education because these infections are a major problem in China. He wanted to disable a gene called CCR5 that forms a protein entry that allows HIV, a virus that causes AIDS, to enter the cell.

All men in the project had HIV and not all women were, but genetic regulation was not aimed at preventing a small risk of transmission, he said. Fathers had their infections thoroughly suppressed with standard HIV drugs and there are simple ways to prevent them from infecting offspring that do not involve the change of genes.

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Instead, the appeal was to offer couples affected by HIV a chance to have a child that could be protected from a similar fate.

He recruited couples through the Beijing Aids Advocacy Group called Baihualin. Her leader, known for the pseudonym "Bai Hua," told AP that it is not unusual for people with HIV to lose their jobs or have problems with medical care if their infections are discovered.

Here's how he described the work:

Editing of the genes occurred during IVF, or breastfeeding in the laboratory. First, sperm is "washed" to separate from the seeds, a fluid in which HIV can charm. One cum is placed in an egg to make an embryo. Then, a gene editing tool is added.

Embrion receives a small dose of Cas9 protein and PCSK9 sgRNA in a microscope for injection of sperm in a laboratory in Shenzhen, Guangdong province, in southern China.

AP Photo / Mark Schiefelbein

When embryos were 3 to 5 days old, several cells were removed and checked for editing. Couples can choose to use processed or unbalanced embryos for pregnancy. In all, 16 out of 22 embryos were edited, and 11 embryos were used in six attempts to implant before double-pregnancy was achieved, he said.

The tests suggest that one twin changed both copies of the intended genome, and the other twin had only one change, without any evidence of damage to other genes, he said. People with a single copy of the genes can still get HIV, although some very limited research suggests that their health can slow down when they do it.

Several scientists reviewed the materials he gave to the AP and said that by now tests are insufficient to say that editing has worked or to eliminate the damage.

They also noticed the evidence that the assembly was incomplete and that at least one twin looked like a muddy cell with various changes.

Zhou Xiaokin adjusts the monitor that displays the video feed of Kin Jinzhou, which moves a fine glass pipette containing Cas9 protein and PCSK9 sgRNA to the embryo under the microscope.

AP Photo / Mark Schiefelbein

"It's almost as if it's not regulated at all," if only some of the cells have changed, because the HIV infection can still occur, the Church said.

The Church and Musoon have called into question the decision to allow one of the embryos to be used in the attempt of pregnancy, as Chinese researchers said they knew in advance that both copies of the intended genes had not been altered.

"In that child, virtually nothing has been achieved in terms of protection against HIV, and you discover this child to all unknown safety risks," Musoonou said.

The use of this embryo suggests that "the main focus of the researchers" was on testing, not on avoiding this disease, "the Church said.

Even if editing works perfectly, people without normal CCR5 genes face a higher risk of getting certain other viruses, such as the Western Nile and flu deaths. Since there are many ways to prevent HIV infection and can be treated if it happens, these other medical risks are of concern, Musoonu said.

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There are also questions about the way he said he continued. He gave an official notice of his work long after he said he had begun – on November 8, in the Chinese Registry of Clinical Trials.

It is unclear whether the participants fully understood the purpose and potential risks and benefits. For example, approval forms are referred to as a project by the AIDS vaccine program.

Scientist Rice, Deem, said he was present in China when potential participants gave their consent and "absolutely" thought they were able to understand the risks.

Deem said he worked with He on a research on the Rice vaccine and believes that genetic regulation is similar to a vaccine.

"It could be an easy way to describe it," he said.

Both men are physicists without experience with clinical trials on humans.

A Chinese scientist, He, said he personally made clear goals and told participants that genetic editing of embryos had never been judged and risked before. He said that he would also provide insurance for all children imagined through the project and planned medical supervision until the children were 18 and if they agreed when they were adults.

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Further pregnancy attempts are pending until the safety of this is analyzed and the experts in the field have not comforted themselves, but participants were not informed in advance that they might not have the opportunity to try what they signed when the "first" was achieved, he acknowledged. Free fertility treatment was part of the deal they offered.

He sought and received approval for his project from the women and children of the Shenzhen Harmonicare hospital, which is not one of the four hospitals he said gave embryos for his research or attempted pregnancy.

Some employees in some other hospitals kept in the dark about the nature of the research, which He and Deem said was done to prevent the detection of some HIV infected participants.

"We think this is ethical," said Lin Zhitong, the Harmonicarea administrator who heads the ethics panel.

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Every medical staff who handled samples that could contain HIV were aware, he said. Embryologist at He's Laboratory, Kin Jinzhou, confirmed to the AP that he was working spermatozoid and injected the gene editing tool in some attempts at pregnancy.

Participants in the studies are not ethics, he said, but "there are so many authorities about what is right and what is wrong, because their life is on the line."

"I believe this will help families and their children," he said. If it causes unwanted side effects or damage, "I would feel the same pain as they did and it will be my responsibility."

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