In this Oct. 10, 2018 photo, He Jiankui is reflected in a glass panel as he works at a computer at a laboratory in Shenzhen in southern China's Guangdong province. Chinese scientist He claims he helped make world's first genetically edited babies: twin girls whose DNA he said he altered. He revealed it Monday, Nov. 26, in Hong Kong to one of the organizers of an international conference on gene editing. (AP Photo/Mark Schiefelbein)

In this Oct. 10, 2018 photo, He Jiankui is reflected in a glass panel as he works at a computer at a laboratory in Shenzhen in southern China's Guangdong province. Chinese scientist He claims he helped make world's first genetically edited babies: twin girls whose DNA he said he altered. He revealed it Monday, Nov. 26, in Hong Kong to one of the organizers of an international conference on gene editing. (AP Photo/Mark Schiefelbein)

HONG KONG (AP) — A Chinese researcher claims that he helped make the world’s first genetically edited babies — twin girls born this month whose DNA he said he altered with a powerful new tool capable of rewriting the very blueprint of life.

If true, it would be a profound leap of science and ethics.

A U.S. scientist said he took part in the work in China, but this kind of gene editing is banned in the United States because the DNA changes can pass to future generations and it risks harming other genes.

Many mainstream scientists think it’s too unsafe to try, and some denounced the Chinese report as human experimentation.

The researcher, He Jiankui of Shenzhen, said he altered embryos for seven couples during fertility treatments, with one pregnancy resulting thus far. He said his goal was not to cure or prevent an inherited disease, but to try to bestow a trait that few people naturally have — an ability to resist possible future infection with HIV, the AIDS virus.

He said the parents involved declined to be identified or interviewed, and he would not say where they live or where the work was done.

There is no independent confirmation of He’s claim, and it has not been published in a journal, where it would be vetted by other experts. He revealed it Monday in Hong Kong to one of the organizers of an international conference on gene editing that is set to begin Tuesday, and earlier in exclusive interviews with The Associated Press.

“I feel a strong responsibility that it’s not just to make a first, but also make it an example,” He told the AP. “Society will decide what to do next” in terms of allowing or forbidding such science.

Some scientists were astounded to hear of the claim and strongly condemned it.

It’s “unconscionable ... an experiment on human beings that is not morally or ethically defensible,” said Dr. Kiran Musunuru, a University of Pennsylvania gene editing expert and editor of a genetics journal.

“This is far too premature,” said Dr. Eric Topol, who heads the Scripps Research Translational Institute in California. “We’re dealing with the operating instructions of a human being. It’s a big deal.”

However, one famed geneticist, Harvard University’s George Church, defended attempting gene editing for HIV, which he called “a major and growing public health threat.”

“I think this is justifiable,” Church said of that goal.

In recent years scientists have discovered a relatively easy way to edit genes, the strands of DNA that govern the body. The tool, called CRISPR-cas9, makes it possible to operate on DNA to supply a needed gene or disable one that’s causing problems.

It’s only recently been tried in adults to treat deadly diseases, and the changes are confined to that person. Editing sperm, eggs or embryos is different — the changes can be inherited. In the U.S., it’s not allowed except for lab research. China outlaws human cloning but not specifically gene editing.

He Jiankui (HEH JEE’-an-qway), who goes by “JK,” studied at Rice and Stanford universities in the U.S. before returning to his homeland to open a lab at Southern University of Science and Technology of China in Shenzhen, where he also has two genetics companies. The university said He’s work “seriously violated academic ethics and standards” and planned to investigate. A spokesman for He confirmed that he has been on leave from teaching since early this year, but he remains on the faculty and has a lab at the school.

The U.S. scientist who worked with him on this project after He returned to China was physics and bioengineering professor Michael Deem, who was his adviser at Rice in Houston. Deem also holds what he called “a small stake” in — and is on the scientific advisory boards of — He’s two companies.

The Chinese researcher said he practiced editing mice, monkey and human embryos in the lab for several years and has applied for patents on his methods.

He said he chose embryo gene editing for HIV because these infections are a big problem in China. He sought to disable a gene called CCR5 that forms a protein doorway that allows HIV, the virus that causes AIDS, to enter a cell.

All of the men in the project had HIV and all of the women did not, but the gene editing was not aimed at preventing the small risk of transmission, He said. The fathers had their infections deeply suppressed by standard HIV medicines and there are simple ways to keep them from infecting offspring that do not involve altering genes.

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

He recruited couples through a Beijing-based AIDS advocacy group called Baihualin. Its leader, known by the pseudonym “Bai Hua,” told the AP that it’s not uncommon for people with HIV to lose jobs or have trouble getting medical care if their infections are revealed.

Here is how He described the work:

The gene editing occurred during IVF, or lab dish fertilization. First, sperm was “washed” to separate it from semen, the fluid where HIV can lurk. A single sperm was placed into a single egg to create an embryo. Then the gene editing tool was added.

When the embryos were 3 to 5 days old, a few cells were removed and checked for editing. Couples could choose whether to use edited or unedited embryos for pregnancy attempts. In all, 16 of 22 embryos were edited, and 11 embryos were used in six implant attempts before the twin pregnancy was achieved, He said.

Tests suggest that one twin had both copies of the intended gene altered and the other twin had just one altered, with no evidence of harm to other genes, He said. People with one copy of the gene can still get HIV, although some very limited research suggests their health might decline more slowly once they do.

Several scientists reviewed materials that He provided to the AP and said tests so far are insufficient to say the editing worked or to rule out harm.

They also noted evidence that the editing was incomplete and that at least one twin appears to be a patchwork of cells with various changes.

“It’s almost like not editing at all” if only some of certain cells were altered, because HIV infection can still occur, Church said.

Church and Musunuru questioned the decision to allow one of the embryos to be used in a pregnancy attempt, because the Chinese researchers said they knew in advance that both copies of the intended gene had not been altered.

“In that child, there really was almost nothing to be gained in terms of protection against HIV and yet you’re exposing that child to all the unknown safety risks,” Musunuru said.

The use of that embryo suggests that the researchers’ “main emphasis was on testing editing rather than avoiding this disease,” Church said.

Even if editing worked perfectly, people without normal CCR5 genes face higher risks of getting certain other viruses, such as West Nile, and of dying from the flu. Since there are many ways to prevent HIV infection and it’s very treatable if it occurs, those other medical risks are a concern, Musunuru said.

There also are questions about the way He said he proceeded. He gave official notice of his work long after he said he started it — on Nov. 8, on a Chinese registry of clinical trials.

It’s unclear whether participants fully understood the purpose and potential risks and benefits. For example, consent forms called the project an “AIDS vaccine development” program.

The Rice scientist, Deem, said he was present in China when potential participants gave their consent and that he “absolutely” thinks they were able to understand the risks.

Deem said he worked with He on vaccine research at Rice and considers the gene editing similar to a vaccine.

“That might be a layman’s way of describing it,” he said.

Both men are physics experts with no experience running human clinical trials.

The Chinese scientist, He, said he personally made the goals clear and told participants that embryo gene editing has never been tried before and carries risks. He said he also would provide insurance coverage for any children conceived through the project and plans medical follow-up until the children are 18 and longer if they agree once they’re adults.

Further pregnancy attempts are on hold until the safety of this one is analyzed and experts in the field weigh in, but participants were not told in advance that they might not have a chance to try what they signed up for once a “first” was achieved, He acknowledged. Free fertility treatment was part of the deal they were offered.

He sought and received approval for his project from Shenzhen Harmonicare Women’s and Children’s Hospital, which is not one of the four hospitals that He said provided embryos for his research or the pregnancy attempts.

Some staff at some of the other hospitals were kept in the dark about the nature of the research, which He and Deem said was done to keep some participants’ HIV infection from being disclosed.

“We think this is ethical,” said Lin Zhitong, a Harmonicare administrator who heads the ethics panel.

Any medical staff who handled samples that might contain HIV were aware, He said. An embryologist in He’s lab, Qin Jinzhou, confirmed to the AP that he did sperm washing and injected the gene editing tool in some of the pregnancy attempts.

The study participants are not ethicists, He said, but “are as much authorities on what is correct and what is wrong because it’s their life on the line.”

“I believe this is going to help the families and their children,” He said. If it causes unwanted side effects or harm, “I would feel the same pain as they do and it’s going to be my own responsibility.”

___

AP science writer Christina Larson, video journalist Emily Wang and researcher Fu Ting contributed to this report from Beijing and Shenzhen, China.

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This Associated Press series was produced in partnership with the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.</s>Hong Kong (CNN) The Chinese government has ordered an "immediate investigation" into the alleged delivery of the world's first genetically edited babies, as experts worldwide voiced outrage at such use of the technology.

The pushback comes amid claims made online by Chinese scientist He Jiankui that twin girls had been born with DNA altered to make them resistant to HIV, a groundbreaking move that is likely to spark significant ethical questions around gene editing and so-called designer babies.

He, a professor at Southern University of Science and Technology in Shenzhen, claims that his lab had been editing embryos' genetic codes for seven couples undergoing in-vitro fertilization.

In a video posted to YouTube on Monday , the Chinese researcher said that one of the pregnancies had been successful and that ostensibly healthy twin girls Lulu and Nana had been born "a few weeks ago."

He claims that he used a tool known as CRISPR-cas9, which can insert or deactivate certain genes. In his YouTube video, He describes the procedure as having "removed the doorway through which HIV enters."

He's claims have neither been independently verified nor peer-reviewed. Editing the genes of embryos intended for pregnancy is banned in many counties, including the United States. In the UK, editing of embryos may be permitted for research purposes with strict regulatory approval. It is unknown whether the procedure is safe or, if used in pregnancy, whether it can have unintended consequences for the babies later in life or for future generations.

China has invested heavily in gene-editing technology, with the government bankrolling research into a number of world "firsts," including the first use of the gene-editing tool CRISPR-Cas9 in humans in 2016 and the first reported use of gene editing technology to modify nonviable human embryos in 2015.

More recently researchers in China claimed to have bred healthy mice from same-sex parents, using gene editing technology.

But in a statement posted Tuesday morning, China's National Health Commission said that it had "immediately requested the Guangdong Provincial Health Commission to seriously investigate and verify" the claims made by He Jiankui.

The statement follows moves by the Chinese hospital named in He's ethical approval documents, Shenzhen Harmonicare Women's and Children's Hospital, to distance itself from involvement in the procedures.

"We can ensure that the research wasn't conducted in our hospital nor were the babies born here," a hospital representative told CNN. The hospital confirmed that two of the doctors named in He's documents work at the hospital and suggested that an internal investigation was underway.

An initial investigation by the hospital said that signatures on He's ethics review form are suspected to be forged. The hospital has never convened an ethics committee meeting on it, according to a statement on its WeChat account , and the facility will ask police to intervene and investigate it and hold related people accountable by law.

The Shenzhen Health and Family Planning Commission denounced the legitimacy of the hospital ethics committee and the review process that approved the application. It confirmed that an investigation was launched Monday to "verify the authenticity of the ethical review of the research reported by media."

He's University, Southern University of Science and Technology, said in a statement that the researcher has been on leave since February 1.

"The research work was carried out outside the school by Associate Professor He Jiankui. He did not report to the school or the department of biology. The university and the biology department are not aware of it," the institution said, adding that "the Academic Committee of the Department of Biology believes that it seriously violates academic ethics and academic norms."

A 'huge blow' to Chinese research

A joint statement issued by more than 120 Chinese scientists on the Chinese social media site Weibo condemns the human genome-editing research.

"The medical ethics review exists in the name only. Directly experimenting on human is nothing but crazy ... as soon as a living human is produced, no one could predict what kind of impact it will bring, as the modified inheritable substance will inevitably blend into human genome pool," they wrote, adding that the trial is a "huge blow" to the reputation of Chinese biomedical research. "It's extremely unfair to Chinese scientist who are diligent, innovative and defending the bottom line of scientific ethics."

Julian Savulescu, director of the Oxford Uehiro Centre for Practical Ethics at the University of Oxford, described the alleged births as "genetic Russian Roulette."

"If true, this experiment is monstrous," he said. "The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer.

"There are many effective ways to prevent HIV in healthy individuals: For example, protected sex. And there are effective treatments if one does contract it," Savulescu said.

Joyce Harper, a professor in genetics and human embryology at the Institute for Women's Health at University College London, described the alleged research "premature, dangerous and irresponsible," calling for public debate and legislation.

Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

"Before this procedure comes anywhere near clinical practice, we need years of work to show that meddling with the genome of the embryo is not going to cause harm to the future person," she said in a statement.

Despite ethical concerns in the West, a recent study suggested that the Chinese public is broadly in favor of using gene-editing for medical purposes. An online survey conducted by Sun Yat-Sen University in Guangzhou found that more than two-thirds of the 4,771 people surveyed (575 of whom reportedly have HIV), supported its use in treating diseases, according to the state-run tabloid Global Times.

"(Chinese people) have a high willingness to use of gene in disease prevention and treatment," Liang Chen, a professor at Sun Yat-Sen University was quoted as saying. "This suggests that the research of gene editing in China not only has a promising potential, but also is responding to the public's needs."</s>A Chinese hospital has denied involvement in the alleged delivery of the world’s first genetically-edited babies and experts worldwide have voiced outrage at such use of the technology.

The push back comes amid claims made online by scientist He Jiankui that twin girls had been born with DNA altered to make them resistant to HIV, a ground-breaking move that could potentially spark huge scientific and ethical dilemmas.

He, a professor at Southern University of Science and Technology in Shenzhen, claims that his lab had been editing embryos’ genetic codes for seven couples undergoing in-vitro fertilization (IVF).

In a video posted to YouTube Monday, the Chinese researcher said that one of the pregnancies had been successful, and that ostensibly healthy twin girls Lulu and Nana had been born “a few weeks ago.”

He claims that he used a tool known as CRISPR-cas9, which can insert or deactivate certain genes. In his YouTube video, He describes the procedure as having “removed the doorway through which HIV enters.”

But the hospital named in He’s ethical approval documents, Shenzhen Harmonicare Women’s and Children’s Hospital, has denied involvement in the procedures.

“We can ensure that the research wasn’t conducted in our hospital nor were the babies born here,” a hospital spokesperson told CNN. The hospital confirmed that two of the doctors named in He’s documents work at the hospital, and suggested that an internal investigation was underway.

The Shenzhen Health and Family Planning Commission denounced the legitimacy of the hospital ethics committee and the review process that approved the application. It confirmed an investigation was launched Monday to “verify the authenticity of the ethical review of the research reported by media.”

He’s University, Southern University of Science and Technology, said in a statement that the researcher has been on leave since February 1, 2018.

“The research work was carried out outside the school by Associate Professor He Jiankui. He did not report to the school or the department of biology. The university and the biology department are not aware of it,” the institution said, adding that “the Academic Committee of the Department of Biology believes that it seriously violates academic ethics and academic norms.”

He’s claims have neither been independently verified nor peer-reviewed. But if true, the procedure would raise significant ethical questions around gene-editing and so-called “designer” babies.

Editing the genes of embryos intended for pregnancy is banned in many counties, including the US. In the UK editing of embryos may be permitted for research purposes with strict regulatory approval. It is unknown whether the procedure is safe or, if used in pregnancy, whether it can have unintended consequences for the babies later in life, or for future generations.

A joint statement has been issued by more than 120 Chinese scientists on the Chinese social media site Wiebo condemning the human genome-editing research.

“The medical ethics review exists in the name only. Directly experimenting on human is nothing but crazy… as soon as a living human is produced, no one could predict what kind of impact it will bring, as the modified inheritable substance will inevitably blend into human genome pool,” they wrote, adding that the trial is a “huge blow” to the reputation of Chinese biomedical research. “It’s extremely unfair to Chinese scientist who are diligent, innovative and defending the bottom line of scientific ethics.”

Julian Savulescu, director of the Oxford Uehiro Centre for Practical Ethics at the University of Oxford, described the alleged births as “genetic Russian Roulette.”

“If true, this experiment is monstrous,” he said. “The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer.

“There are many effective ways to prevent HIV in healthy individuals: For example, protected sex. And there are effective treatments if one does contract it,” Savulescu said.

Joyce Harper, a professor in genetics and human embryology at the Institute for Women’s Health, UCL, described the alleged research “premature, dangerous and irresponsible,” calling for public debate and legislation.

“Before this procedure comes anywhere near clinical practice, we need years of work to show that meddling with the genome of the embryo is not going to cause harm to the future person,” she said in a statement.

Yalda Jamshidi, senior lecturer in human genetics, St George’s, University of London pointed out that such controversial research is not necessary for preventing HIV. “We already have ways to prevent HIV infection and available treatments should it occur. We also do not need gene editing to ensure it isn’t passed on to offspring,” she said. “We know very little about the long term effects, and most people would agree that experimentation on humans for an avoidable condition just to improve our knowledge is morally and ethically unacceptable.

Despite ethical concerns in the West, a recent study suggested that the Chinese public is broadly in favor of using gene-editing for medical purposes. An online survey conducted by Sun Yat-Sen University in Guangzhou found that more than two-thirds of the 4,771 people surveyed (575 of whom reportedly have HIV), supported its use in treating diseases, according to the state-run tabloid Global Times.

“(Chinese people) have a high willingness to use of gene in disease prevention and treatment,” Liang Chen, a professor at Sun Yat-Sen University is quoted as saying. “This suggests that the research of gene editing in China not only has a promising potential, but also is responding to the public’s needs.”</s>A Chinese scientist who studied in the U.S. said Monday that he created the first genetically edited babies who were born earlier in November and were modified to be unable to contract HIV.

The alleged gene editing sparked an outcry from many in the scientific community who say there is not enough research to justify exposing children to the potential downsides of the experimentation.

Scientist He Jiankui’s claims have not been verified by independent experts, but he told The Associated Press that he edited two embryos made with the sperm of an HIV-positive father who was one of seven participating in He’s program. Those two embryos, twin girls, were implanted in a mother without HIV.

The identities of the people involved in the study have not been revealed, in part because of stigma against HIV-positive individuals in China, according to the AP.

He studied at Rice and Stanford universities, both prestigious schools located in the U.S., and now works at the Southern University of Science and Technology of China. He also owns two genetics companies in China, reported the AP.

“I feel a strong responsibility that it’s not just to make a first, but also make it an example,” He told the AP. “Society will decide what to do next.”

He made the announcement a day before the International Summit on Human Genome Editing begins in Hong Kong Tuesday, according to the MIT Technology Review.

Many countries, including the U.S., ban the type of gene editing He said he performed because edited DNA can be passed down to future generations. The method is also “associated with off-target mutations, capable of causing genetic problems … including the development of cancer,” said Julian Savulescu, the Uehiro Chair in Practical Ethics at Oxford University.

“If true, this experiment is monstrous. The embryos were healthy. No known diseases,” Savulescu said in a statement Monday. “There are many effective ways to prevent HIV in healthy individuals … In many other places in the world, this would be illegal punishable by imprisonment.”

Scientist He said he used a tool called CRISPR-cas9 to delete a gene called CCR5 that acts as a “doorway” to allow the HIV virus to enter a cell, according to the AP.

CRISPR-cas9 is called a “molecular scissor” and has been used to edit genes in adults with deadly diseases, a technique the U.S. Food and Drug Administration has encouraged. The technique has even been used to treat hemophilia, a genetic disorder that keeps blood from clotting properly.

Those DNA edits in adults are not heritable, but the edits He said his team made would be heritable.

The twins He said were born after he genetically engineered them as embryos are being referred to as “Lulu” and “Nana.” It appears that one twin had both copies of the CCR5 gene edited while the other twin only had one copy edited, He said.

He’s trial involved seven couples, and the scientist used 11 embryos in six implant attempts before Lulu and Nana implanted, according to the AP.

Editing embryos’ genes is allowed in the U.S. only in laboratory research. But some Americans would support the technique spreading outside the lab in the future. Seventy-two percent of respondents believed that embryonic gene editing to “to treat a serious disease or condition that the baby would have at birth” is an appropriate use of technology, according to Pew survey conducted in April and May.

A version of this article appeared on The Daily Caller News Foundation website.

We are committed to truth and accuracy in all of our journalism. Read our editorial standards.</s>Chinese Scientist Says He's First To Genetically Edit Babies

For the first time, a scientist claims to have used a powerful new gene-editing technique to create genetically modified human babies.

The scientist, He Jiankui of the Southern University of Science and Technology in Shenzen, China, says he used human embryos modified with the gene-editing technique CRISPR to create twin girls.

"Two beautiful little Chinese girls name Lulu and Nana came crying into the world as healthy as any other babies a few weeks ago." He says in a video posted online. "The babies are home now with their mom Grace and their dad Mark."

He says his team performed "gene surgery" on embryos created from their parents' sperm and eggs to protect the children from the human immunodeficiency virus (HIV), which causes AIDS. The childrens' father is HIV-positive.

"When Lulu and Nana were just a single cell, this surgery removed a doorway through which HIV enter to infect people," He says in the video, one of several posted online to justify and explain the work.

Because the research has not yet been published in a scientific journal or carefully vetted by other scientists, many researchers and bioethicists remain cautious about the claim.

But, if true, many said the move would be historic, comparing it to the birth of Louise Brown, the first baby created through in-vitro fertilization, IVF.

"This event might be analogous to Louise Brown in 1978," wrote George Church, a prominent Harvard geneticist, in an email. "Both anecdotal — yet healthy baby girls can have an impact," Church wrote.

He and Church are among hundreds of scientists gathering at the Second International Summit on Human Gene Editing in Hong Kong. The summit was organized try to reach a global consensus on whether and how it would be ethical to create genetically modified human beings with CRISPR.

He's claims immediately sparked widespread criticism from attendees at the summit and elsewhere.

"This work is a break from the cautious and transparent approach of the global scientific community's application of CRISPR-Cas9 for human germline editing," Jennifer Doudna, a biochemist at the University of California, Berkeley, said in an interview. Doudna helped discover CRISPR and organize the summit.

"All of us that are here at this conference are struggling to figure out what was done and also whether the process was done properly. We just don't know yet," says Jennifer Doudna says.

But the claim "really reinforces the urgent need to confine the use of gene-editing in human embryos to settings where there's a clear unmet medical need and where there's no alternative viable approach," says Doudna. She does not think that is the case in this situation.

"If this was done to avoid HIV infection, there are alternative ways to prevent infection that are already effective," Doudna says, such as "washing" the sperm of infected men to eliminate HIV.

"Why would you use this instead of an already established approach?" Doudna says.

For their research, He and his colleagues say they used CRISPR to make changes in one-day old embryos in a gene called CCR5. The CCR5 gene enables HIV to enter and infect immune system cells. Scientists have long searched for ways to block this pathway to protect people from HIV.

He's team used CRISPR to edit 16 embryos, and implanted 11 edited embryos into the wombs of women to attempt to create a viable pregnancy before the twin pregnancy was achieved, according to the Associated Press, which first reported He's claims.

"No gene was changed except the one to prevent HIV infection," He says. The twins appear to be healthy, and underwent detailed genetic analysis. "This verified the gene surgery worked safely," He says.

Nevetheless, other scientists questioned whether the editing really worked, an argue it was far too soon for the team to try the experiment.

"It is premature at this stage of technology," wrote Shoukhrat Mitalipov, a scientist at the Oregon Health & Sciences University in Portland, Ore. Mitalipov was the first scientist to report using CRISPR to successfully edit human embryos, but stopped far short of trying to use them to make babies.

"Although I appreciate the global threat posed by HIV, at this stage, the risks of editing embryos to knock out CCR5 seem to outweigh the potential benefits," wrote Feng Zhang, a CRISPR pioneer at MIT. Zhang noted that knocking out the CCR5 gene "will likely render a person much more susceptible for West Nile Virus."

CRISPR enables scientists to make very precise changes in DNA much more easily than ever before. As a result, it's revolutionizing scientific research and raising high hopes for major breakthroughs, including preventing and treating many diseases.

But making changes in human DNA that could be passed down for generations has long been considered off-limits. One reason is that a mistake could introduce a new disease that could be passed down for generations. Another is that it could open the door to "designer babies" — children that are modified for non-medical reasons, such as to be taller, stronger or smarter.

"If it's true as reported, then it's an extremely premature and questionable experiment in creating genetically modified children," agrees Jeffrey Kahn, a bioethicist at Johns Hopkins Berman Institute of Bioethics attending the Hong Kong summit.

But the development of CRISPR has prompted some scientists to re-think that prohibition for medical purposes. And researchers around the world have been racing to determine how it could be done safely. Many scientists believe it is inevitable, but should be restricted to situations where no alternative is available.

"If true, this amounts to unethical and reckless experimentation on human beings, and a grave abuse of human rights," said Marcy Darnovsky, executive director of the Center for Genetics and Society, a genetic watchdog group.

"Throwing open the door to a society of genetic haves and have-nots undermines our chances for a fair and just future," Darnovsky says.

He acknowledges his work could spark criticism, but defends the step.

"I understand my work will be controversial. But I believe families need this technology. And I am will to take the criticism for them," He says.</s>A Chinese scientist has claimed that he has helped birth the world's first-ever genetically edited babies — a pair of twin girls. Their DNA was reportedly altered using a new and powerful tool called CRISPR-Cas9. He Jiankui says it is now possible to rewrite the very blueprint of life.

If He Jiankui's claims are true, this development would be a profound leap in the field of genetics as well as scientific ethics, points out an AP report.

An American scientist has also reportedly taken part in the experiment in China. Gene editing on humans is banned in the US, notes the report, because modifying genes and making changes in the DNA could possibly move from one generation to the next and there is an ever-present threat to the health of other genes as well.

It is said that many mainstream scientists feel like gene-editing humans are too unsafe to try, and others are said to have denounced this Chinese research as it being akin to human experimentation.

He Jiankui of Shenzhen, who goes by "JK", the scientist who carried out this research, told AP that he modified the embryos for seven couples when they were undergoing fertility treatments. So far, says JK, it has resulted in one pregnancy.

JK says the goal was not to cure or prevent any diseases that a child might inherit but to try and give it a trait that a small percentage of humans naturally have—the ability to possibly resist future HIV infections. HIV is responsible for AIDS and a cure for the disease is yet to be found.

He claims that the parents involved in the study have declined to be interviewed, and also refused to disclose the location of where the research was carried out.

AP has also said that, so far, there is no independent analysis or any confirmation of He and his work, and it is yet to be published in a peer-reviewed journal so that it can be thoroughly vetted by other researchers and experts in the field. JK spoke of his study this week in Hong Kong, notes the report, to one organizer of an international conference on gene editing and has also spoken to the AP on what his research has found so far.

"I feel a strong responsibility that it's not just to make a first, but also make it an example," He told the AP. "Society will decide what to do next" in terms of allowing or forbidding such science.

Fellow members of the scientific community have strongly condemned He's work.

It's "unconscionable... an experiment on human beings that is not morally or ethically defensible," said Dr Kiran Musunuru, a gene-editing expert from the University of Pennsylvania.

"This is far too premature," added Dr Eric Topol, who heads the Scripps Research Translational Institute in California. "We're dealing with the operating instructions of a human being. It's a big deal."

George Church, from Harvard, however, defended this research. More so because it deals with HIV, the disease, he says, is "a major and growing public health threat."

"I think this is justifiable," Church said of trying to combat it.

HIV, according to the WHO's Global Health Observatory Data, is a global epidemic where more than 70 million people have been infected and about 35 million people have died.

Gene editing is a process of modifying strands of DNA that controls the entire body. It can be easily edited using a tool called CRISPR-Cas9. It can effectively perform operations on the DNA directly and theoretically, one can supply a needed gene to the strands or even disable the one that's causing problems, notes AP.

JK said he was able to gain practice by editing mice, monkey, and human embryos in labs for several years. He has even applied for patents for some of his methods as a result of his study.

Embryo gene editing for HIV was chosen because it is a major health issue in China. As to how exactly JK has gone about it, he says that he sought to disable the CCR5 gene. It forms something of a protein doorway which allows HIV to enter a cell, eventually reproduces rapidly and take over the immune system.

All the men involved in this project were HIV positive and all the women were not. The target of the gene editing research, however, was not aimed at preventing a risk of transmission. All the male subjects had their HIV infections suppressed by HIV medicines that are now easily available all over the world and there are ways to keep the infection from spreading to their babies that already exist and they do not involve and gene altering.

The research, however, was to offer HIV positive people a way to have children with immunity to the deadly virus.

JK then went on explain the process—gene editing, he says, was carried out during IVF or lab fertilisation. First, the sperm cells were "washed" to separate them from semen, this is where HIV could possibly be found. A single sperm cell, he says, was placed into a single egg and an embryo was thus formed. It is at this point that the gene editing was carried out.

At around 3 to 5 days old, a few cells were taken from the embryo and checked if it was possible to edit them. At this point, couples were told that they could choose whether to use edited or unedited embryos for their pregnancy attempts. In the research, says JK, 16 out of 22 embryos were edited. Eleven edited embryos were then used in six implant attempts before one of the couples were able to achieve the twin pregnancy, He said.

So far, one of the twins had both copies of the edited gene-altered while the other twin had just one altered. There is also no evidence of any harm to the embryos' other genes.

In general, those with one copy of the gene can still contract HIV, but there are chances that their rate of decline, when it comes to health could happen more slowly if they do.

A number of scientists have so far reviewed data that He gave to the AP, notes the report. They have said that the tests so far are insufficient. There is not enough evidence to conclusively state whether or not the editing worked so far as to rule out harm caused to the embryos.

"It's almost like not editing at all" if only certain cells go through alteration, HIV infection can still occur, Church said.

The use of that embryo suggests that the researchers' "main emphasis was on testing editing rather than avoiding this disease," Church said.</s>Scientists have been abuzz with excitement ever since it became clear that CRISPR would unlock a new world of powerful gene editing techniques. Teams around the world have experimented with CRISPR-based gene editing techniques in human embryos, but no one has allowed those embryos to become living, breathing people — until now. A Chinese team claims to have used CRISPR to make two infants that are resistant to HIV infection.

The CRISPR/Cas9 system was derived from bacterial cells and allows scientists to make precise cuts in DNA. Cas9 is the enzyme that actually makes the cut, but it needs CRISPR DNA sequences as a guide to find the right location in a genome. Researchers have used CRISPR in the lab to neuter disease-carrying mosquitoes, halt HIV replication inside cells, and engineer bacteria that can eat plastic. There is no scientific consensus on the ethics of editing genes in human embryos for the purpose of reproduction, but now we may be seeing the world’s first “designer babies.”

According to He Jiankui of the Southern University of Science and Technology in Shenzhen, his team used CRISPR to edit the genes of human embryos that eventually became twin girls Lulu and Nana. The change to the twins’ CCR5 gene causes their cells to carry a mutated form of the CCR5 protein. This mutation should protect them from HIV infection.

In a video posted after the announcement, He Jiankui explains why they chose to focus on HIV first. While medication can control HIV and prevent the development of AIDS, we know some people won’t develop an infection even when exposed to the virus. HIV uses CCR5 to gain access to white blood cells, where it replicates and goes on to infect more cells. As a result, the CCR5 gene is one of the most studied in the human genome, and we’ve identified a variant that blocks HIV. Those with the mutated CCR5 gene don’t have the matching cell surface protein for HIV, so the virus particles can’t get into cells. The gene editing procedure in China replicated this mutation in day-old embryos to imbue the resulting babies with the same resistance.

The team created 16 edited embryos and implanted 11 of them in women before the twin pregnancy occurred. He Jiankui says the twins are healthy and have undergone genetic testing to ensure the modified gene was present and no other genes had been changed.

It’s important to stress that this research has not yet been published in a peer-reviewed journal. The Southern University of Science and Technology also issued a statement that it was not involved in the experiment, which took place at an outside facility. Scientists around the world are expressing a mix of skepticism and shock following the announcement. Many of them say that using CRISPR to create modified humans is reckless when the technology is still so new. If the results are confirmed, there are serious ethical questions to consider. Chinese medical authorities are pledging to investigate.

Now read: Scientists Use CRISPR to Block HIV Replication Inside Living Cells, CRISPR Gene Editing May Have Unanticipated Side Effects, and Could We Be the Last Generation to Know What the Flu Feels Like?</s>A Chinese researcher claims he helped make the world’s first genetically edited babies — twin girls whose DNA he said he altered with a powerful new tool capable of rewriting the very blueprint of life.

If true, it would be a profound leap of science and ethics.

A US scientist said he took part in the work in China, but this kind of gene editing is banned in the United States because the DNA changes can pass to future generations and it risks harming other genes.

Many mainstream scientists think it is too unsafe to try, and some denounced the Chinese report as human experimentation.

The researcher, He Jiankui of Shenzhen, said he altered embryos for seven couples during fertility treatments, with one pregnancy resulting thus far.

He said his goal was not to cure or prevent an inherited disease, but to try to bestow a trait that few people naturally have — an ability to resist possible future infection with HIV, the AIDS virus.

He said the parents involved declined to be identified or interviewed, and he would not say where they live or where the work was done.

There is no independent confirmation of Mr He’s claim, and it has not been published in a journal, where it would be vetted by other experts.

He revealed it on Monday in Hong Kong to one of the organisers of an international conference on gene editing that is set to begin on Tuesday.

“I feel a strong responsibility that it’s not just to make a first, but also make it an example,” Mr He told the AP. “Society will decide what to do next” in terms of allowing or forbidding such science, he added.

Some scientists were astounded to hear of the claim and strongly condemned it.

Dr Kiran Musunuru, a University of Pennsylvania gene editing expert and editor of a genetics journal, said it was “unconscionable … an experiment on human beings that is not morally or ethically defensible”.

“This is far too premature,” said Dr Eric Topol, who heads the Scripps Research Translational Institute in California. “We’re dealing with the operating instructions of a human being. It’s a big deal.”

However, one famed geneticist, Harvard University’s George Church, defended attempting gene editing for HIV, which he called “a major and growing public health threat”.

In recent years, scientists have discovered a relatively easy way to edit genes, the strands of DNA that govern the body.

The tool, called CRISPR-cas9, makes it possible to operate on DNA to supply a needed gene or disable one that is causing problems.

It has only recently been tried in adults to treat deadly diseases, and the changes are confined to that person.

Editing sperm, eggs or embryos is different — the changes can be inherited. China outlaws human cloning but not specifically gene editing.

Mr He studied at Rice and Stanford universities in the US before returning to his homeland to open a lab at Southern University of Science and Technology of China in Shenzhen, where he also has two genetics companies.

The US scientist who worked with him on this project after Mr He returned to China was physics and bioengineering professor Michael Deem, who was his adviser at Rice in Houston.

The Chinese researcher said he practised editing mice, monkey and human embryos in the lab for several years and has applied for patents on his methods.

He said he chose embryo gene editing for HIV because these infections were a big problem in China. He sought to disable a gene called CCR5 that forms a protein doorway that allows HIV, the virus that causes AIDS, to enter a cell.

All of the men in the project had HIV and all of the women did not, but the gene editing was not aimed at preventing the small risk of transmission, Mr He said.

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

He said the gene editing occurred during IVF, or lab dish fertilisation. First, sperm was “washed” to separate it from semen, the fluid where HIV can lurk. A single sperm was placed into a single egg to create an embryo. Then the gene editing tool was used.

When the embryos were three to five days old, a few cells were removed and checked for editing. Couples could choose whether to use edited or unedited embryos for pregnancy attempts. Eleven embryos were used in six attempts before the twin pregnancy was achieved, Mr He said.

Tests suggest that one of the twins, born this month, had both copies of the intended gene altered and the other twin had just one altered, with no evidence of harm to other genes, Mr He said. People with one copy can still get HIV.

Several scientists reviewed materials that Mr He provided to the AP and said tests so far were insufficient to draw conclusions.

“I believe this is going to help the families and their children,” said Mr He. If it causes unwanted side effects or harm, “I would feel the same pain as they do and it’s going to be my own responsibility”, he added.</s>A scientist claims to have helped create the world's first genetically-modified humans during laboratory work in China.

The DNA of twin girls was altered with a powerful new tool capable of rewriting the very blueprint of life, Chinese researcher Dr He Jiankui says.

He claims the babies, named LuLu and Nana, were born a few weeks ago and have a resistance to infection with HIV, the AIDS virus.

A US scientist said he took part in the work in China, but this kind of gene editing is banned in the United States due to risks that altered DNA will warp other genes.

These potentially dangerous changes may then be passed down to future generations.

Gene editing is banned in Britain, the US many other parts of the world, and researchers said that, if Dr He's claims are true, the 'monstrous' experiment was 'not morally or ethically defensible.'

Dr Jiankui, of the Southern University of Science and Technology, in Shenzhen, said he altered embryos for seven couples during fertility treatments, with one pregnancy resulting thus far.

He said his goal was not to cure or prevent an inherited disease, but to try to bestow a trait that few people naturally have - an ability to resist infection with HIV.

He said the parents involved declined to be identified or interviewed, and would not say where they live or where the work was done.

There is no independent confirmation of Dr He's claim, and it has not been published in a journal, where it would be vetted by other experts.

He announced the research Monday in Hong Kong to an organiser of an international conference on gene editing that is set to begin Tuesday, and earlier in exclusive interviews with The Associated Press.

'I feel a strong responsibility that it's not just to make a first, but also make it an example,' he told the AP.

Society will decide what to do next' in terms of allowing or forbidding such science.

Some scientists were astounded to hear of the claim and strongly condemned it.

It's 'unconscionable ... an experiment on human beings that is not morally or ethically defensible,' said Dr Kiran Musunuru, a University of Pennsylvania gene editing expert and editor of a genetics journal.

'This is far too premature,' said Dr Eric Topol, who heads the Scripps Research Translational Institute in California. 'We're dealing with the operating instructions of a human being. It's a big deal.'

'If true, this experiment is monstrous,' said Professor Julian Savulescu, Director of the University of Oxford's Uehiro Centre for Practical Ethics.

'These healthy babies are being used as genetic guinea pigs. This is genetic Russian Roulette.'

However, one famed geneticist, Harvard University's Professor George Church, defended attempting gene editing for HIV, which he called 'a major and growing public health threat.'

'I think this is justifiable,' Professor Church said of that goal.

In recent years scientists have discovered a relatively easy way to edit genes, the strands of DNA that govern the body.

The tool, called CRISPR-cas9, makes it possible to operate on DNA to supply a needed gene or disable one that's causing problems.

It's only recently been tried in adults to treat deadly diseases, with all edits confined to that person, meaning they cannot be passed down to their children.

Editing sperm, eggs or embryos is different - the changes can be inherited.

In the US, it's not allowed except for lab research. China outlaws human cloning but not specifically gene editing.

Dr He Jiankui (HEH JEE'-an-qway), who goes by 'JK,' studied at Rice and Stanford universities in the US before returning to his homeland to open a lab at Southern University of Science and Technology of China in Shenzhen, where he also has two genetics companies.

The US scientist who worked with him on this project after Dr He returned to China was physics and bioengineering Professor Michael Deem, who was his adviser at Rice in Houston.

Professor Deem also holds what he called 'a small stake' in - and is on the scientific advisory boards of - Dr He's two companies.

The Chinese researcher said he practiced editing mice, monkey and human embryos in the lab for several years and has applied for patents on his methods.

Dr He said he chose to try embryo gene editing for HIV because these infections are a big problem in China.

He sought to disable a gene called CCR5 that forms a protein doorway that allows HIV, the virus that causes AIDS, to enter a cell.

All of the men in the project had HIV and all of the women did not, but the gene editing was not aimed at preventing the small risk of transmission, Dr He said.

The fathers had their infections deeply suppressed by standard HIV medicines and there are simple ways to keep them from infecting offspring that do not involve altering genes.

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

Its leader, known by the pseudonym 'Bai Hua,' told the AP that it's not uncommon for people with HIV to lose jobs or have trouble getting medical care if their infections are revealed.

Describing the work, Dr He said: 'The gene editing occurred during IVF, or lab dish fertilisation.

'First, sperm was 'washed' to separate it from semen, the fluid where HIV can lurk. A single sperm was placed into a single egg to create an embryo. Then the gene editing tool was added.

'When the embryos were three to five days old, a few cells were removed and checked for editing.

'Couples could choose whether to use edited or unedited embryos for pregnancy attempts.

'In all, 16 of 22 embryos were edited, and 11 embryos were used in six implant attempts before the twin pregnancy was achieved,' Dr He said.

Tests suggest that one twin had both copies of the intended gene altered and the other twin had just one altered, with no evidence of harm to other genes, Dr He said.

People with one copy of the gene can still get HIV, although some very limited research suggests their health might decline more slowly once they do.

Several scientists reviewed materials that Dr He provided to the AP and said tests so far are insufficient to say the editing worked or to rule out harm.

They also noted evidence that the editing was incomplete and that at least one twin appears to be a patchwork of cells with various changes.

'It's almost like not editing at all' if only some of certain cells were altered, because HIV infection can still occur, Church said.

Church and Musunuru questioned the decision to allow one of the embryos to be used in a pregnancy attempt, because the Chinese researchers said they knew in advance that both copies of the intended gene had not been altered.

'In that child, there really was almost nothing to be gained in terms of protection against HIV and yet you're exposing that child to all the unknown safety risks,' Musunuru said.

The use of that embryo suggests that the researchers' 'main emphasis was on testing editing rather than avoiding this disease,' Church said.

Even if editing worked perfectly, people without normal CCR5 genes face higher risks of getting certain other viruses, such as West Nile, and of dying from the flu.

Since there are many ways to prevent HIV infection and it's very treatable if it occurs, those other medical risks are a concern, Musunuru said.

There also are questions about the way Dr He said he proceeded.

He gave official notice of his work long after he said he started it - on November 8, on a Chinese registry of clinical trials.

It's unclear whether participants fully understood the purpose and potential risks and benefits.

For example, consent forms called the project an 'AIDS vaccine development' program.

The Rice scientist, Professor Deem, said he was present in China when potential participants gave their consent and that he 'absolutely' thinks they were able to understand the risks.

Professor Deem said he worked with Dr He on vaccine research at Rice and considers the gene editing similar to a vaccine.

'That might be a layman's way of describing it,' he said.

Both men are physics experts with no experience running human clinical trials.

The Chinese scientist, Dr He, said he personally made the goals clear and told participants that embryo gene editing has never been tried before and carries risks.

Dr He said he also would provide insurance coverage for any children conceived through the project and plans medical followup until the children are 18 and longer if they agree once they're adults.

Further pregnancy attempts are on hold until the safety of this one is analyzed and experts in the field weigh in, but participants were not told in advance that they might not have a chance to try what they signed up for once a 'first' was achieved, Dr He acknowledged.

Free fertility treatment was part of the deal they were offered.

Dr He sought and received approval for his project from Shenzhen Harmonicare Women's and Children's Hospital, which is not one of the four hospitals that Dr He said provided embryos for his research or the pregnancy attempts.

Some staff at some of the other hospitals were kept in the dark about the nature of the research, which Dr He and Professor Deem said was done to keep some participants' HIV infection from being disclosed.

'We think this is ethical,' said Lin Zhitong, a Harmonicare administrator who heads the ethics panel.

Any medical staff who handled samples that might contain HIV were aware, Dr He said.

An embryologist in Dr He's lab, Qin Jinzhou, confirmed to the AP that he did sperm washing and injected the gene editing tool in some of the pregnancy attempts.

The study participants are not ethicists, Dr He said, but 'are as much authorities on what is correct and what is wrong because it's their life on the line.'

'I believe this is going to help the families and their children,' Dr He said.

If it causes unwanted side effects or harm, 'I would feel the same pain as they do and it's going to be my own responsibility.'

This article has been adapted from its original source.</s>He Jiankui, a Chinese researcher, is claiming to have successfully used the genetic editing tool CRISPR-Cas9 to alter the DNA of two twin baby girls. A researcher at the Southern University of Science and Technology of China in Shenzhen, He claims that he has given the girls an ability to resist possible future HIV infection.

Declining to name the parents of the children or offer any independent verification of the work, there is still skepticism that He, who has degrees from Stanford and Rice, has actually done it. Cases of scientific fraud in high-stakes breakthroughs, like South Korean researcher Woo Suk Hwang's cloning claims, still loom large. But if He has genetically altered the two children, it is a monumental step forward for CRISPR technology.

“I feel a strong responsibility that it’s not just to make a first, but also make it an example,” He told the Associated Press. As for laws governing genetic engineering, He says, “society will decide what to do next.”

CRISPR's potential to treat serious diseases has been known for years, although scientists are unsure how many people are actually immune to the procedure.

He claims that he chose the HIV virus, the infection that can lead to AIDS, because the disease is a growing problem in China. In September, the Chinese government announced a 14 percent rise in the number of citizens living with HIV or AIDS, with 40,000 new cases reported in the second quarter of 2018. He has also put out a series of YouTube videos describing his reasoning for choosing to focus on HIV as well as the ethics of his actions.

He claims to have edited the embryos of seven couples during in vitro fertilization (IVF), in which an egg and sperm are combined outside the body. In all seven cases, the men had HIV and the women did not. The couples were recruited through an AIDS advocacy group called Baihualin, which works against societal discrimination of those infected with the disease.

He focused on disabling a gene well-known to HIV researchers: CCR5, a protein on the surface of white blood cells. HIV commonly uses the CCR5 protein to enter cells. By disabling the CCR5 doorway, He's work would block off one of the HIV virus's most common routes of infection.

Genetic alternations made during the IVF stage can be inherited by future children, the prospect of which has made such testing illegal in the United States. While China has laws outlawing cloning, no such regulations prevent gene editing.

Laws aside, the announcement has been met with severe backlash across the scientific community. Focus has been not just on general morality but also on He's choice of target. While CCR5 is a gateway for HIV, it also works to prevent mosquito-associated diseases like West Nile virus.

In a strenuous statement, one of the inventors of CRISPR technology, Feng Zhang of MIT and Harvard, said that, "Although I appreciate the global threat posed by HIV, at this stage, the risks of editing embryos to knock out CCR5 seem to outweigh the potential benefits, not to mention that knocking out of CCR5 will likely render a person much more susceptible for West Nile Virus. Just as important, there are already common and highly-effective methods to prevent transmission of HIV from a parent to an unborn child."

"Given the current state of the technology, Feng continues, "I'm in favor of a moratorium on implantation of edited embryos, which seems to be the intention of the CCR5 trial, until we have come up with a thoughtful set of safety requirements first."
A Chinese scientist claims to be the first person to edit the genome of a human baby, by targeting an immune-receptor which is used by HIV (CCR5). This has provoked denial from the hospital and international outcry.