A Chinese researcher claims that he has helped create the world's first genetically modified baby & # 39; s twin girls born this month that he said he changed it with a powerful new tool that is capable of blueprint of life to rewrite.
If it is true, it would be a profound leap of science and ethics.
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An American scientist said he participated in work in China, but this type of gene processing is banned in the United States because the DNA changes can be passed on to future generations and there is a risk of damaging other genes.
Many regular scientists think it is too unsafe to try, and some criticized the Chinese report as human experiments.
The researcher, He Jiankui of Shenzhen, said that he changed embryo for seven couples during fertility treatments, with one resultant pregnancy so far. He said that his goal was not to cure or prevent a hereditary disease, but to try to give a trait that few people naturally have – a potential for future infection with HIV, the AIDS virus. to resist.
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He said that the parents involved refused 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 is not published in a journal where it would be screened by other experts. He unveiled it Monday in Hong Kong to one of the organizers of an international conference on gene editing that starts Tuesday and earlier in exclusive interviews with The Associated Press.
"I feel a strong responsibility that it is not only to make a scoop, but also to make an example of it," he told the AP. "Society will decide what to do next" in terms of allowing or prohibiting such science.
Some scientists were astonished to hear the claim and strongly condemned it.
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It is "unreasonable … an experiment on human beings that is not morally or ethically defensible," Dr. Kiran Musunuru, an expert in gene editing and editor of a genetic diary from the University of Pennsylvania.
"This is far too premature," Dr. Eric Topol, head of the Scripps Research Translationational Institute in California. "We are dealing with the operating instructions of a human being, it is a big deal."
However, a famous geneticist, the George Church at Harvard University, defended the attempt at gene processing for HIV, which he & # 39; a major and growing public health threat & # 39; called.
"I think this is justifiable," Church said about that goal.
In recent years, scientists have discovered a relatively simple way to process genes, the strands of DNA that control the body. The tool, called CRISPR-cas9, makes it possible to work on DNA to deliver a needed gene or to disable a gene that causes problems.
It has only recently been tried in adults to treat deadly diseases, and the changes are limited to that person. Editing semen, eggs or embryo's is different – the changes can be inherited. In the US it is not allowed, except for laboratory research. China prohibits human cloning, but not specifically for processing genes.
He Jiankui, who goes with "JK", studied at Rice and Stanford universities in the United States before returning to his native country to open a laboratory at the Southern University of Science and Technology of China in Shenzhen, where he also held two genetics companies.
The American scientist who worked with him on this project after returning to China was professor of physics and bio-engineering Michael Deem, who was his adviser at Rice in Houston. Deem also keeps what he calls "a small deposit" – and is in the scientific advisory boards of – He is two companies.
The Chinese researcher said that he has been practicing mice, monkey and human embryos in the laboratory for several years and has applied for patents for his methods.
He said that he chose HIV-editing for HIV because these infections are a big problem in China. He tried to disable a gene called CCR5 and a passage for the protein that allows HIV, the virus that causes AIDS, to enter a cell.
All men in the project did not have HIV and all women, but gene processing was not intended to prevent the small risk of transmission, he said. The fathers had their infections deeply suppressed by standard HIV drugs and there are simple ways to prevent them from infecting offspring where no genes are changed.
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Instead, it was a call to give HIV couples a chance to have a child that could be protected against a similar fate.
He recruited couples through a Beijing-based AIDS advocacy group called Baihualin. The leader, known under the pseudonym # Bai Hua #, told the AP that it is not uncommon for people with HIV to lose jobs or have trouble with medical care if their infections are revealed.
Here is how He described the work:
Gene processing took place during IVF or lab dish fertilization. First, semen was "washed" to separate it from semen, the fluid that HIV can lurk on. A single sperm was placed in a single egg to make an embryo. Then the tool for editing genes has been added.
When the embryos were three to five days old, some cells were removed and checked for processing. Couples could opt for the use of processed or unprocessed embryos for pregnancy attempts. In total, 16 of the 22 embryos were modified and 11 embryos were used in six implantation attempts before the twin pregnancy was achieved, he said.
Tests suggest that one twin had altered both copies of the target gene and the other twins had only changed one, without evidence of damage to other genes, he said. People with one copy of the gene can still get HIV, although some very limited studies suggest that their health declines more slowly as they do so.
Several scientists have discussed materials that he has provided to the AP and the tests so far are insufficient to say that the operation worked or to exclude damage.
They also found evidence that the operation was incomplete and that at least one twin appears to be a patchwork of cells with different modifications.
"It's almost as if it's not being edited at all" if only a few of certain cells were changed, because HIV infection can still occur, the church said.
Church and Musunuru wondered if one of the embryos could be used during a pregnancy attempt, because the Chinese researchers knew in advance that both copies of the target gene had not changed.
"In that child there was virtually nothing to gain in terms of protection against HIV and yet you expose that child to all unknown safety risks," said Musunuru.
The use of that embryo suggests that the researchers' focus was on testing the editing rather than avoiding this disease, "the church said.
Even if editing works perfectly, people without normal CCR5 genes run a higher risk of getting certain other viruses, such as West Nile, and to die from the flu. Since there are many ways to prevent HIV infection and it can be treated very well if it occurs, those other medical risks are a problem, Musunuru said.
There are also questions about how He said that he went further. He gave official notice of his work long after he said he started it – on November 8, about a Chinese register of clinical trials.
It is unclear whether participants fully understood the objective 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 are capable of understanding the risks.
Deem said that he collaborated with him on the vaccine study at Rice and considers the processing of genes comparable to a vaccine.
"That might be the way a layman describes it," he said.
Both men are physic experts without experience in conducting clinical trials in humans.
The Chinese scientist, he, said he made the targets clear and told the participants that embryo processing has never been tried before and involves risks. He said that he would also offer insurance cover for all children conceived during the project and plans medical follow-up until the children are 18 and longer if they agree when they are adults.
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Further attempts at pregnancy are suspended until the safety of these is analyzed and experts in the field are taken into account, but participants were not told in advance that they might not have the opportunity to try what they were enrolled for, once there was 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 the Shenzhen Harmonicare Women & # 39; s Hospital, which is not one of the four hospitals that he said contained embryos for his research or pregnancy attempts .
Some of the staff of a few other hospitals were kept in the dark about the nature of the research, of which He and Deem said it was done to prevent the HIV infection of some participants from being revealed.
"We think this is ethical," said Lin Zhitong, a Harmonicare administrator who heads the ethics panel.
All medical staff who treated samples that possibly contained HIV knew that, he said. An embryologist at He, Qin Jinzhou's laboratory, confirmed to AP that he had washed sperm and injected the gene-processing tool during several attempts at pregnancy.
The study participants are not ethicists, he said, but "are as many authorities about what is correct and what is wrong, because their lives are at stake."
"I believe this will help the families and their children," he said. If it causes unwanted side effects or damage, "I would feel the same pain as them and it will be my own responsibility."