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UK approves mitochondrial donation babies

19 December 2016
Appeared in BioNews 882

The UK has become the first country in the world to formally approve the creation of IVF embryos through mitochondrial donation.

On 15 December 2016, following a scientific report into the efficacy and safety of the procedure (see BioNews 880), the Human Fertilisation and Embryology Authority (HFEA) ruled that the therapy should be approved for 'cautious clinical use'. The UK government legalised mitochondrial replacement therapy (MRT) in 20312.

Fertility clinics can now apply for a licence to carry out MRT to prevent mitochondrial disease, meaning that the first babies could potentially be born around this time next year.

'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,' said Sally Cheshire, chair of the HFEA. 'We feel now is the right time to carefully introduce this new treatment in the limited circumstances recommended by the panel.'

Mitochondrial diseases are caused by faulty mitochondria that cause incurable, progressive failure in tissues such as the brain, heart and muscles. As mitochondria are passed on solely from the mother via the cytoplasm of the egg cell, MRT involves replacing the faulty mitochondria of the egg with healthy mitochondria from a donor egg.

A team of specialists at Newcastle University, where the technique was pioneered, is expected to be the first to be granted a licence. They hope to treat up to 25 women per year. The NHS has said it will provide £8 million in funding for a five-year clinical trial.

Mary Herbert, Professor of Reproductive Biology at Newcastle University, said: 'We welcome today's decision from the HFEA, and 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.'

After applying for a licence to carry out the procedure, a second licence will need to be obtained for each patient, who will be reviewed on a case-by-case basis.

Professor Sir Mark Walport, the government's Chief Scientific Adviser, said: 'I welcome this careful and considered assessment by the HFEA. The UK leads the world in the development of new medical technologies. This decision demonstrates that, thanks to organisations like the HFEA, we also lead the world in our ability to have a rigorous public debate around their adoption.'

The world's first mitochondrial donation baby was born in a clinic in Mexico earlier this year, where no national laws currently exist to regulate the practice (see BioNews 871). The medical director of the clinic, Dr Alejandro Chávez Badiola, has recently announced plans to treat 20 more women in the first half of 2017.

5 February 2018 - by Sam Sherratt 
The Human Fertilisation and Embryology Authority (HFEA) has granted permission for doctors to create the UK's first 'three-person' children by mitochondrial donation.
22 May 2017 - by Dr Peter Mills 
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3 April 2017 - by Helen Robertson 
Details of the world's first successful use of mitochondrial replacement therapy in IVF have been published...
20 March 2017 - by Georgia Everett 
Doctors at Newcastle Fertility Centre have been granted the first UK licence to use mitochondrial replacement therapy as a fertility treatment to prevent the inheritance of mitochondrial disease...
23 January 2017 - by Antony Blackburn-Starza 
A baby has been born in the Ukraine following the use of an experimental IVF procedure known as mitochondrial donation...
5 December 2016 - by Dr Julia Hill 
Scientists advising the HFEA have recommended that the technique of mitochondrial replacement therapy be approved for clinical use in the UK...
17 October 2016 - by Ayala Ochert 
Two women in the Ukraine are pregnant with babies conceived through mitochondrial donation as a treatment for infertility, according to a report in New Scientist...
3 October 2016 - by Dr Julia Hill 
In a world first, the birth of a baby boy who was conceived using mitochondrial donation has been reported...
2 November 2015 - by Dr Katie Howe 
Regulations that came into force this week will enable the UK to be the first country in the world to allow the use of mitochondrial donation techniques during IVF...
2 March 2015 - by Sandy Starr 
The House of Lords has voted by 280 to 48 to pass regulations permitting mitochondrial donation. This makes the UK the first country in the world to legislate for the use of mitochondrial donation techniques in treatment...
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