Share
Three-Parent Babies a step closer after regulations grant approval

Three-Parent Babies a step closer after regulations grant approval

Occasionally in the world of science, a breakthrough comes along that is so startling that it turns conventional thinking on its head.

That is the case with the latest research into the idea of three-person IVF, which challenges the belief that a child will always have two biological parents.

The new technique has been developed by scientists seeking to prevent babies from inheriting often lethal genetic diseases.

Following protracted investigations into the scientific and ethical implications of the procedure, it has now been approved by UK fertility regulator the Human Fertilisation and Embryology Authority (HFEA).

As a result of the decision, the first ‘three-parent’ babies could be born in the UK at the end of this year, in work that builds on pioneering research by a team at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University.

It was in 2015 that the UK became the first country to legalise mitochondrial replacement therapy (MRT) and the HFEA’s follow-up decision in December 2016 cleared the way for clinics to apply for permission to carry out the treatment.

Mitochondrial diseases are caused by inherited mutations in the DNA contained in mitochondria, tiny structures present in every cell. They are genetic conditions affecting the batteries of the cell, with about one in 4,300 affected children born every year. Symptoms include muscle weakness, blindness, deafness, seizures, learning disabilities, diabetes, heart and liver failure. There is no cure for mitochondrial DNA disease and affected children often die in early infancy.

Known as ‘mitochondrial donation’ the new IVF technique involves replacing faulty mitochondria inherited from the mother in the egg with the healthy mitochondria of another woman.

Following the HFTEA decision, the Newcastle team immediately applied for a licence to help patients who risk transmitting mitochondrial disease to their children by using the procedure, which transfers a tiny amount of DNA from the second woman’s egg into the first women’s egg.

The procedure will be carried out on women receiving treatment as an NHS service at the Newcastle Fertility Centre and the NHS Highly Specialised Service for Mitochondrial Disease and the team aim to offer treatment for up to 25 women a year affected by mitochondrial disease.

The procedure is not without its critics, who argue that it paves the way for the creation of ‘designer babies’, thereby interfering with the natural order of things.

During lengthy consultation, the HFEA considered such objections along with the safety of the procedure and concluded that the health benefits outweighed the ethical concerns.

HFEA Chair Sally Cheshire said: “This 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.

“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.

“Although it is tempting to rush ahead with new treatments, the UK approach of testing public opinion, putting the issue to parliament and carefully monitoring laboratory research has proved to be the most responsible and sustainable of introducing new, cutting edge treatments into the clinic. Such an approach has allowed us to balance innovation with safety, maintaining public trust as we go.”

Wellcome Director Dr Jeremy Farrar agreed that time needed to be taken to weigh up the issues, saying: “It’s right that there’s been such a thorough process to get to this stage. We must recognise, though, that for some affected families this decision may have come too late. The scientific community must continue to work closely with policy and the regulatory system so future innovative, cutting-edge techniques reach patients faster.”  

For the Newcastle team, the priority has always been the welfare of families whose lives have been blighted by the disease.

Professor Mary Herbert from the Wellcome Centre for Mitochondrial Disease at Newcastle University and the Newcastle Fertility Centre, who led the IVF research leading to the developments, said: “It is enormously gratifying that our many years of research in this area can finally be applied to help families affected by these devastating diseases.”

Such views find an echo in comments from James Palmer, Clinical Director of Specialised Services at NHS England, who said: “Mitochondrial diseases can be devastating and life limiting as well as hugely costly to the NHS to treat. This trial will, for the first time, give women living with mitochondrial disease the option of having a baby without passing on their condition and is a shining example of how the NHS is leading the world in developing cutting-edge innovative new medical interventions.”Occasionally in the world of science, a breakthrough comes along that is so startling that it turns conventional thinking on its head.

That is the case with the latest research into the idea of three-person IVF, which challenges the belief that a child will always have two biological parents.

The new technique has been developed by scientists seeking to prevent babies from inheriting often lethal genetic diseases.

Following protracted investigations into the scientific and ethical implications of the procedure, it has now been approved by UK fertility regulator the Human Fertilisation and Embryology Authority (HFEA).

As a result of the decision, the first ‘three-parent’ babies could be born in the UK at the end of this year, in work that builds on pioneering research by a team at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University.

It was in 2015 that the UK became the first country to legalise mitochondrial replacement therapy (MRT) and the HFEA’s follow-up decision in December 2016 cleared the way for clinics to apply for permission to carry out the treatment.

Mitochondrial diseases are caused by inherited mutations in the DNA contained in mitochondria, tiny structures present in every cell. They are genetic conditions affecting the batteries of the cell, with about one in 4,300 affected children born every year. Symptoms include muscle weakness, blindness, deafness, seizures, learning disabilities, diabetes, heart and liver failure. There is no cure for mitochondrial DNA disease and affected children often die in early infancy.

Known as ‘mitochondrial donation’ the new IVF technique involves replacing faulty mitochondria inherited from the mother in the egg with the healthy mitochondria of another woman.

Following the HFTEA decision, the Newcastle team immediately applied for a licence to help patients who risk transmitting mitochondrial disease to their children by using the procedure, which transfers a tiny amount of DNA from the second woman’s egg into the first women’s egg.

The procedure will be carried out on women receiving treatment as an NHS service at the Newcastle Fertility Centre and the NHS Highly Specialised Service for Mitochondrial Disease and the team aim to offer treatment for up to 25 women a year affected by mitochondrial disease.

The procedure is not without its critics, who argue that it paves the way for the creation of ‘designer babies’, thereby interfering with the natural order of things.

During lengthy consultation, the HFEA considered such objections along with the safety of the procedure and concluded that the health benefits outweighed the ethical concerns.

HFEA Chair Sally Cheshire said: “This 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.

“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.

“Although it is tempting to rush ahead with new treatments, the UK approach of testing public opinion, putting the issue to parliament and carefully monitoring laboratory research has proved to be the most responsible and sustainable of introducing new, cutting edge treatments into the clinic. Such an approach has allowed us to balance innovation with safety, maintaining public trust as we go.”

Wellcome Director Dr Jeremy Farrar agreed that time needed to be taken to weigh up the issues, saying: “It’s right that there’s been such a thorough process to get to this stage. We must recognise, though, that for some affected families this decision may have come too late. The scientific community must continue to work closely with policy and the regulatory system so future innovative, cutting-edge techniques reach patients faster.”  

For the Newcastle team, the priority has always been the welfare of families whose lives have been blighted by the disease.

Professor Mary Herbert from the Wellcome Centre for Mitochondrial Disease at Newcastle University and the Newcastle Fertility Centre, who led the IVF research leading to the developments, said: “It is enormously gratifying that our many years of research in this area can finally be applied to help families affected by these devastating diseases.”

Such views find an echo in comments from James Palmer, Clinical Director of Specialised Services at NHS England, who said: “Mitochondrial diseases can be devastating and life limiting as well as hugely costly to the NHS to treat. This trial will, for the first time, give women living with mitochondrial disease the option of having a baby without passing on their condition and is a shining example of how the NHS is leading the world in developing cutting-edge innovative new medical interventions.”

Leave a Comment