First live birth using human oocytes reconstituted by spindle nuclear transfer for mitochondrial DNA mutation causing Leigh syndrome
A five-month-old boy is the first baby to be born using a new technique that incorporates DNA from three parents, New Scientist reveals, 27 September 2016.
Five MII oocytes with birefringent spindles were subjected to meiotic SNT. The 5 oocytes were successfully reconstituted and fertilized normally by ICSI. Four out of 5 fertilized oocytes developed into blastocysts. PGS showed that one blastocyst was euploid (46XY), while 3 embryos were aneuploid. The average transmission rate of maternal mtDNA in the biopsied euploid blastocyst was 5.10 ± 1.11% and the heteroplasmy level for 8993T>G was 5.73%. Transfer of the euploid embryo resulted in an uneventful pregnancy with delivery of a healthy boy at 37 weeks of gestation. The average level of transmitted mother’s mtDNA in several neonatal tissues including buccal epithelium, hair follicles, circumcised foreskin, urine precipitate, placenta, amnion, umbilical blood, and umbilical cord was less than 1.60 ± 0.92%.
First live birth using human oocytes reconstituted by spindle nuclear transfer for mitochondrial DNA mutation causing Leigh syndrome, Fertility and Sterility, S0015-0282(16)62670-5, October 2016.
Human oocytes reconstituted by SNT are capable of producing a healthy live birth. SNT may provide a novel treatment option in minimizing pathogenic mtDNA transmission from mothers to their babies.
Are genetically modified embryos “essential” for science?
Research involving genetic modification of human embryos, though controversial, is essential to gain basic understanding of the biology of early embryos and should be permitted, an international group of experts said.
The statement was issued by members of the so-called Hinxton Group, a global network of stem cell researchers, bioethicists and policy experts who met in the UK last week.
But critics say once the technology is allowed for research purposes, it is inevitable it will end up creating a market for enhanced, genetically modified babies.
Sources and more information
Statement on Genome Editing Technologies and Human Germline Genetic Modification, hinxtongroup, September 3-4, 2015.
Genetically modified human embryos should be allowed, expert group says, theguardian, 10 September 2015.
Genetically modified embryos “essential” for science, in-cyprus, 10/09/2015.
‘Genetic modification of embryos is essential’: Report claims editing genomes holds huge potential and shouldn’t be feared, DailyMail, 10 September 2015.
The United Kingdom is on course to become the first country to allow in vitro fertilisation (IVF) to create babies using biological material from three people to prevent serious inherited disease, after MPs voted overwhelmingly in favour of the procedure, reports the BMJ.
The UK House of Commons voted by 382 to 128 to approve regulations allowing mitochondrial donation, after MPs were given a free vote of conscience on the issue.
It is currently unknown how effective it may be, or what the short- or long-term consequences are
A modelling study estimated the three-person IVF technique, currently illegal, could be used for thousands of women with genes linked to serious mitochondrial DNA diseases.
There was an initial debate on mitochondrial donation in the House of Commons on the 1st of September 2014. The Muscular Dystrophy Campaign, Newcastle University, The Lily Foundation and Wellcome Trust are organising a drop-in MP briefing session on Tuesday 3rd February from 12.30pm to 2pm in Committee Room 10.
The three-person IVF is designed to prevent babies being born with mitochondrial conditions by usinge healthy mitochondria from a donor egg to replace the mitochondria in the mother’s egg, either before fertilisation or just after, to prevent passing on mutations.
The study estimated almost 2,500 women of child-bearing age in the UK, and almost 12,500 women in the US could benefit from the new IVF technique. As this technique is untried, it is currently unknown how effective it may be, or what the short- or long-term consequences are.
Sources and more information
Mitochondrial Donation — How Many Women Could Benefit?, NEJM, 2015DOI: 10.1056/NEJMc1500960, January 28.
Two and a half thousand women could benefit from mitochondrial donation in the UK, Newcastle University, 28th January 2015.
Thousands of UK women could benefit from ‘three-person’ IVF, NHS Choices, January 29 2015.
Leading figures express support for mitochondrial donation, Wellcome Trust, 29 JAN, 2015.
Government Decision on Mitochondria Replacement Regulations
The Government has today announced its intention to put regulations relating to mitochondria replacement before Parliament.
Earlier this year, the Department of Health commissioned the HFEA to reconvene its expert panel of scientists to conduct a review into the safety and efficacy of techniques relating to mitochondria replacement.The panel was clear that it had seen no evidence which suggested that mitochondrial replacement is unsafe and that good progress was being made on the science.
Dr Andy Greenfield, chair of the HFEA’s expert panel of scientists, said:
“Our understanding of mitochondria has developed significantly over recent years, and scientists in the UK and the US are now close to providing new treatment options for a range of serious conditions that are inherited through the mothers’ mitochondria. In three years study the expert panel has seen no evidence which suggests that these new mitochondrial replacement therapies are unsafe. The scientific direction of travel is clear; and although we have recommended further experiments before treatment should be offered we understand that good progress on these is being made and we expect them to support the conclusions we have reached to date.”
“Moving from research into clinical practice always involves a degree of uncertainty. If Parliament does change the law the regulatory processes required by the HFEA before treatment can be offered will ensure, to the extent that assurance can ever be offered, that mitochondrial replacement works and is sufficiently safe to be offered to people with serious mitochondrial disease.”
Sally Cheshire, Chair of the HFEA, said :
“The HFEA was first asked by the Government to provide expert advice on this important issue in 2011. Since then we have produced three separate reports on the science and one on public attitudes. Our advice shows that the science is moving rapidly in the right direction and that a majority of the public support these new treatment options for what are serious, and sometimes fatal, inherited conditions. Taken together, these reports provide an evidence base which is a model for public policy making, especially when considering the introduction of new techniques at the cutting edge of biology and ethics.”
“The decision to change the law is, quite properly, for Parliament and today the Government has signalled its intention to introduce Regulations. But even if the law is changed that doesn’t mean that treatments will be offered overnight. As the regulator, the HFEA will need to design and implement a process to ensure that clinics are licensed against rigorous standards – the public would expect nothing less.”
Should Parliament pass the regulations, the HFEA will need to consider how any mitochondria replacement therapies could be licensed. We look forward to working with the Department of Health to develop a rigorous approval process.
Sources and Six Years of BBC Press Releases:
Government decision on mitochondria replacement regulations, HFEA, press release, 22 July 2014.
Three person IVF plans ‘progress’ in UK,
BBC News Health, health-28417860, 22 July 2014.
Three-person babies ‘in two years’ – says science review,
BBC News Health, health-27678464, 03 June 2014.
Why make babies from three people?,
BBC News Health, health-27682884, 03 June 2014.
Three-person baby details announced,
BBC News Health, health-26367220, 27 February 2014.
UK government backs three-person IVF,
BBC News Health, health-23079276, 28 June 2013.
A bold step for science and society,
BBC News Health, health-23086162, 28 June 2013.
Three-person IVF: Your stories,
BBC News Health, health-23096105, 28 June 2013.
Three-person IVF moves closer in UK,
BBC News Health, health-21806911, 20 March 2013.
The woman who lost all seven children,
BBC News Health, magazine-19648992, 20 September 2012.
Should genetically modified human embryos be allowed?
Great Britain is on the path to allow a technique to create babies using DNA from three people in a bid to help prevent couples passing on rare genetic diseases. The technique, which scientists say would not create a ‘three parent child’, helps prevent women with faulty mitochondria, the energy source in a cell, from passing on to their babies defects that can result in such diseases as muscular dystrophy, epilepsy, heart problems and mental retardation. The debate is causing controversy as Parliament gears up to making a decision on whether the technique should be made legal. Opponents say it is unethical and could set the UK on a “slippery slope”.
Should genetically modified human embryos be allowed?
Following the news that the controversial fertility treatment developed in the UK Newcastle University – which could eradicate incurable inherited diseases – had the public’s backing, UK chief medical officer, Professor Dame Sally Davies, has announced that draft regulations will be published within months. Professor Dame Sally Davies predicts that couples affected by mitochondrial disease could benefit from the treatment within two years, enabling them to have healthy children.