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Sun, Dec 9, 2018
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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.’

Scroll down for video 

He Jiankui speaks during an interview at a laboratory in Shenzhen in southern China’s Guangdong province. The Chinese scientist claims he helped make world’s first genetically edited babies: Twin girls whose DNA he claims to have altered

HOW DID DR HE DESCRIBE THE WORK? 

‘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 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.

This image shows a microplate containing embryos that have been injected with Cas9 protein using the controversial gene editing tool Crispr. The image was taken at Dr He's laboratory in Shenzhen last month

This image shows a microplate containing embryos that have been injected with Cas9 protein using the controversial gene editing tool Crispr. The image was taken at Dr He’s laboratory in Shenzhen last month

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 DNA of twin girls was altered with a powerful new tool capable of rewriting the very blueprint of life, Chinenese researcher Dr He Jiankui says. Pictured id Dr He (left) with fellow researcher Zhou Xiaoqin at a laboratory in Shenzhen

The DNA of twin girls was altered with a powerful new tool capable of rewriting the very blueprint of life, Chinenese researcher Dr He Jiankui says. Pictured id Dr He (left) with fellow researcher Zhou Xiaoqin at a laboratory in Shenzhen

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.

WHAT ARE SOME OF THE DOUBTS SURROUNDING DR HE’S CLAIMS?

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, famed Harvard University geneticist Professor George Church said.

Church and Dr Kiran Musunuru, a University of Pennsylvania gene editing expert, 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,’ Dr 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, Dr 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.

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.

Dr 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.

The researchers used a gene-editing tool called CRISPR-cas9 for their experiment, which makes it possible to operate on DNA. This image shows a video feed of a researcher in Dr He's team using the tool under a microscope

The researchers used a gene-editing tool called CRISPR-cas9 for their experiment, which makes it possible to operate on DNA. This image shows a video feed of a researcher in Dr He’s team using the tool under a microscope

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.

WHAT IS CRISPR-CAS9?

CRISPR-Cas9 is a tool for making precise edits in DNA, discovered in bacteria.

The acronym stands for ‘Clustered Regularly Inter-Spaced Palindromic Repeats’.

The technique involves a DNA cutting enzyme and a small tag which tells the enzyme where to cut.

The CRISPR/Cas9 technique uses tags which identify the location of the mutation, and an enzyme, which acts as tiny scissors, to cut DNA in a precise place, allowing small portions of a gene to be removed

The CRISPR/Cas9 technique uses tags which identify the location of the mutation, and an enzyme, which acts as tiny scissors, to cut DNA in a precise place, allowing small portions of a gene to be removed

By editing this tag, scientists are able to target the enzyme to specific regions of DNA and make precise cuts, wherever they like.

It has been used to ‘silence’ genes – effectively switching them off.

When cellular machinery repairs the DNA break, it removes a small snip of DNA.

In this way, researchers can precisely turn off specific genes in the genome.

The approach has been used previously to edit the HBB gene responsible for a condition called β-thalassaemia. 

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.

Zhou Xiaoqin removes the cryostorage sheath from a container for an embryo at Dr He's laboratory in Shenzhen in southern China's Guangdong province

Zhou Xiaoqin removes the cryostorage sheath from a container for an embryo at Dr He’s laboratory in Shenzhen in southern China’s Guangdong province

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. 

In this image an embryo is injected with proteins using the controversial Crispr-Cas9 technique

In this image an embryo is injected with proteins using the controversial Crispr-Cas9 technique

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.

WHAT IS EPIGENETICS?

Epigenetics is a field of molecular science which involves altering the expression of certain genes. 

It is defined as: ‘The study of changes in organisms caused by modification of gene expression rather than alteration of the genetic code itself.’

Instead of changing the genes present in a living thing, it changes which of its genes are ‘turned on’. 

Although it is the genetic code which forms the foundations for every living organism, it is the combination of activated genes which defines it.

This gene expression can be complex or simple and can control a wide range of features. 

As some features and behaviours are controlled by single genes, these can be easily altered by turning this gene off, for example. 

Some genes inhibit growth and limit cell proliferation, by deactivating these genes things can be grown which do not have the same natural limitations as before. 

This can, and has, led to larger, and bigger foods – mainly seen in the fruit and vegetable sector.

The process is completely harmless, as it does not introduce any artificial or ‘unnatural’ products. 

One of the most common forms of epigenetics is Crispr-Cas9, which is a specific technique that can edit, activate or deactivate cell.

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.

In this photo, Zhou Xiaoqin (left) loads Cas9 protein and PCSK9 sgRNA molecules into a fine glass pipette as Qin Jinzhou watches

In this photo, Zhou Xiaoqin (left) loads Cas9 protein and PCSK9 sgRNA molecules into a fine glass pipette as Qin Jinzhou watches

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.’



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