Human Fertilisation and Embryology Authority

U.K. Approves Fertilization Treatment Using DNA From Multiple People to Make Babies

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IN BRIEF
  • Clinics in the UK can now offer patients mitochondrial donation, a treatment that uses DNA from a third person to help women with mitochondrial diseases give birth to healthy babies.
  • Despite criticism that mitochondrial donation will one day lead to “designer babies,” the only certainty is that it can help patients right now overcome a problem with no other solution.

ONE BABY, THREE PARENTS

The United Kingdom’s fertility regulator will now begin accepting applications from clinics seeking to offer patients mitochondrial donation. The treatment has been proven to help women with mitochondrial DNA mutations give birth to healthy babies, and the Human Fertilisation and Embryology Authority’s (HFEA) approval for the technique has been deemed a historic step forward in this field.

The process involves the removal of the nucleus DNA from the egg of the mother carrying the mitochondrial disease and transferring it to a donor egg. The egg is fertilized with the father’s sperm, and the embryo is then implanted in the mother. That embryo will therefore have nucleus DNA from its parents, but mictochondrial DNA from a donor, though the third-party DNA will account for less than one percent of the embryo’s genes.

“Today’s historic decision means that parents at very high risk of having a child with a life-threatening mitochondrial disease may soon have the chance of a healthy, genetically related child. This is life-changing for those families,” says HFEA Chair Sally Cheshire in a statement.

A mitochondrial donation at a Mexican clinic resulted in the successful birth of a three-parent baby earlier this year, and the team behind that case recently announced plans to treat as many as 20 new patients in the first half of 2017.

Micrograph showing ragged red fibers, a finding seen in various types of mitochondrial diseases. Image Credit: Nephron/Wikimedia

LIFE-CHANGING TREATMENT

Women with mitochondrial disorders have a high risk of passing on the mutated DNA to their offspring. In most cases, the affected child will die early due to the lack of available treatment options or suffer debilitating condition such as muscular dystrophy, organ failure, and muscle weakness.

Prior to the availability of mitochondrial donation, women with faulty mitochondria who wanted to have children were limited to adoption or undergoing in vitro fertilization (IVF) using healthy donor eggs. If they wanted to push for genetically related offspring, they would have to risk natural birth or undergo a screening procedure that could potentially help doctors find embryos with the fewest mutations.

Despite being a viable and better alternative to existing options, the procedure is not universally embraced. Critics have asserted that the DNA manipulation the technique requires could eventually lead to the creation of “designer babies.” However, as it provides a solution to a condition for which there is currently no better option, the value of this breakthrough is enormous.

Receiving the green light from regulatory bodies proves that advancements that could save lives and have positive life-changing implications right now will garner support despite any hypothetical future scenarios. “After a lot of hard work and invaluable advice from the expert panel, who reviewed the development, safety, and efficacy of these techniques over five years and four reports, we feel now is the right time to carefully introduce this new treatment in the limited circumstances recommended by the panel,” says Cheshire.

Warning of three-person IVF ‘risks’

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Concerns about the safety of a pioneering therapy that would create babies with DNA from three people have been raised by researchers.

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The advanced form of IVF could eliminate debilitating and potentially fatal mitochondrial diseases.

Writing in the journal Science, the group warned that the mix of DNA could lead to damaging side-effects.

The expert panel that reviewed the safety of the technique said the risks described would be “trivial”.

The UK is leading the world in the field of “mitochondrial replacement”. Draft regulations to allow the procedure on a case-by-case basis will be produced this year and some estimate that therapies could be offered within two years.

“Start Quote

One of our prime interests is about the safety of these techniques.”

Prof Doug Turnbull Mitochondrial replacement researcher

Mitochondria are the tiny, biological “power stations” that provide nearly every cell, which make up the body, with energy. They are passed from a mother, through the egg, to her child.

But if the mother has defective mitochondria then it leaves the child starved of energy, resulting in muscle weakness, blindness and heart failure. In the most severe cases it is fatal and some families have lost multiple children to the condition.

The proposed therapy aims to replace the defective mitochondria with those from a donor egg.

Continue reading the main story

Method one: Embryo repair 1) Two eggs are fertilised with sperm, creating an embryo from the intended parents and another from the donors 2) The pronuclei, which contain genetic information, are removed from both embryos but only the parents’ is kept 3) A healthy embryo is created by adding the parents’ pronuclei to the donor embryo, which is finally implanted into the womb

Continue reading the main story

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But mitochondria have their own DNA, albeit a tiny fraction of the total. It means a baby would have genetic information from mum, dad and a second woman’s mitochondria.

The concerns raised – by scientists at the University of Sheffield, the University of Sussex and Monash University in Australia – are about a poor match between the mitochondrial DNA and that from the parents.

The woman who lost all her children

Sharon Bernardi and her son Edward, who died last year aged 21

Every time Sharon Bernardi became pregnant, she hoped for a healthy child.

But all seven of her children died from a rare genetic disease that affects the central nervous system – three of them just hours after birth.

When her fourth child, Edward, was born, doctors discovered the disease was caused by a defect in Sharon’s mitochondria.

Edward was given drugs and blood transfusions to prevent the lactic acidosis (a kind of blood poisoning) that had killed his siblings.

Five weeks later Sharon and her husband, Neil, were allowed to take Edward to their home in Sunderland for Christmas – but his health slowly began to deteriorate.

Edward survived into adulthood, dying in 2011 at the age of 21.

Now Sharon is supporting medical research that would allow defective mitochondria to be replaced by DNA from another woman.

They said there was an interaction between the DNA in the mitochondria and the rest which is packaged in a cell’s nucleus.

Their studies on fruit flies suggested that a poor match of genetic information between the nucleus and mitochondria could affect fertility, learning and behaviour.

“Describing it as like changing the batteries in a camera is too simplistic,” Dr Klaus Reinhardt from the University of Sheffield told the BBC.

He added : “It is not at all our intention to be a roadblock, we think it is fantastic that for women affected there could be a cure.

“We have pointed out one or two points which need to be looked at.”

‘Trivial’

The Human Fertilisation and Embryology Authority, which regulates fertility treatment in the UK, commissioned a review into the safety of the technique.

Prof Robin Lovell-Badge, who was on the review panel, disagreed. He said humans had diverse mitochondrial and nuclear DNA, so any consequences of poor matches would have already become apparent.

He told the BBC news website: “Humans are breeding between races and producing healthy children all the time. If there is an effect then it must be very trivial as it’s not been noticed.”

He has called for further safety testing, such as research into the risks posed by any defective mitochondria which might still be passed onto a child.

Prof Doug Turnbull, who is developing the mitochondrial replacement therapy at Newcastle University, insisted: “One of our prime interests is about the safety of these techniques.

“It’s perfectly reasonable to draw some of these concerns, I just don’t share the same concerns.

“Mismatch between the mitochondrial and nuclear genome is a potential risk, but I don’t think it’s personally as big a risk as they’re saying.”

Mitochondrion
Hundreds of mitochondria in every cell provide energy

The idea has also raised ethical concerns from groups concerned about the impact of altering human genetic inheritance.

In a statement, the Human Fertilisation and Embryology Authority said: “The panel of experts convened by the HFEA to examine the safety and efficacy of mitochondria replacement carefully considered the interaction between nuclear and mitochondrial DNA and concluded that the evidence did not show cause for concern.

“As in every area of medicine, moving from research into clinical practice always involves a degree of uncertainty. Experts should be satisfied that the results of further safety checks are reassuring and long term follow-up studies are crucial.

“Even then patients will need to carefully weigh up the risk and benefits for them.”

Three-person IVF moves closer in UK.

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The UK has moved closer to becoming the first country to allow the creation of babies from three people.

The Human Fertilisation and Embryology Authority (HFEA) has advised the government that there is no evidence the advanced forms of IVF were unsafe.

The fertility regulator’s public consultation also showed “general support” for the idea as the benefits outweighed the risks.

A final decision on whether to press ahead rests with ministers.

If the techniques were approved it could help a handful of families each year. Around one in 6,500 children develop serious “mitochondrial disorders” which are debilitating and fatal.

Research suggests that using mitochondria from a donor egg can prevent the diseases.

However, it would result in babies having DNA from two parents and a tiny amount from a third donor.

Concerns have been raised both about the safety and the ethics of creating such babies.

The results of a public consultation at the end of 2012 showed there was support for the idea.

Prof Neva Haites, who was on the expert panel supervising the consultation, said: “Broadly speaking the public was in favour of these novel techniques being translated into treatments.

“They felt that any ethical concerns were outweighed by potential benefits.”

One of the main issues raised was of a “slippery slope” which could lead to other forms of genetic modification.

‘Power stations’

Mitochondria are the tiny biological power stations that give energy to nearly every cell of the body.

Defects can leave the body starved of energy, resulting in muscle weakness, blindness, heart failure and death in the most extreme cases.

The cigar-shaped mitochondria are passed only from mother to child. A father does not pass on his mitochondria through his sperm.

Scientists have devised two techniques that allow them to take the genetic information from the mother and place it into the egg of a donor with healthy mitochondria. It is like taking two fried eggs and switching the yolks.

The result is a baby with genetic information from three people, as mitochondria have their own genes in their own DNA.

The implications are not just for the couple and the child. If the therapy was performed it would have ramifications through the generations as scientists would be altering human genetic inheritance.

‘Recommendations’

The HFEA has advised that any changes to the law should be only for the modification of mitochondria to overcome serious diseases and that there should still be a ban on changes to the main nuclear DNA, which contains the vast majority of a person’s genetic code.

It also recommended continuing research and that any children born through these techniques, and possible the children’s children, be monitored closely.

Any time soon?

These therapies using sperm and eggs from three people are not yet ready to be performed in the clinic. However, it is thought that scientists in the UK and the US are getting close to the point where it will be possible.

Prof Robin Lovell-Badge, part of the expert panel analysing the science, said there was “still no evidence to suggest the techniques are unsafe,” but he said further experiments were needed for reassurance.

“Safety is absolutely not a black and white issue. In reproductive medicine in particular it is not possible to be absolutely certain about the consequences of any new treatment until children are born.

“Someone at some point is going to have to take the brave decision to go ahead with it.”

Some of the researchers involved believe they may be ready to make the leap in three to five years – if everything goes to plan, something which is by no means certain.

There was vigorous discussion at the HFEA Open Meeting, where the advice to ministers was agreed, around issues of identification. In sperm and egg donation the donor is identified.

The meeting agreed to advise ministers that there should be no right for the child to know the identity of the donor, however, the HFEA will tell ministers that public opinion was mixed.

Mr Hossam Abdalla, clinical director of the Lister Fertility Clinic in London, told the meeting: “If a child wants to know about that, why are we so restrictive… why are we telling them we they can’t have this access?”

‘Astounded’

Prof Lisa Jardine, chairwoman of the HFEA, said the UK was in one of the most advanced positions in the world.

“Other countries are astounded that we’re this far on in the discussions,” she said.

However, she pointed out the techniques would be used only for mitochondrial disorders: “This is not a Rubicon or a slippery slope.”

One of the pioneers of the field, Prof Doug Turnbull, from Newcastle University, said: “The techniques we are working on could help hundreds of women have healthy children.”

He said more research was required, but it was now “crucial” that the government approved the techniques in the UK.

The Department of Health said mitochondrial diseases could have a “devastating impact” on families and it would consider the HFEA’s advice.

Making three-person IVF legal would not require a new act of Parliament, but would require a vote in both the Commons and the Lords.

Speaking after the meeting Dr David King, the director of Human Genetics Alert, said: “Historians of the future will point to this as the moment when technocrats crossed the crucial line, the decision that led inexorably to the disaster of genetically engineered babies and consumer eugenics.

“This was the moment at which they casually tossed the bioethical consensus of the last 30 years into the trash. And for what?

“Not so mothers could avoid having sick babies, because they could do that already, through egg donation. It was so that a few dozen mothers who insisted they must be genetically related to their child could be satisfied.”

Source:BBC