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Mitochondrial replacement IVF: discussions begin in USA

21 October 2013
Appeared in BioNews 727

The health regulator in the USA is considering whether clinical trials of mitochondrial replacement (MR) techniques should go ahead.

The Food and Drug Administration (FDA) received a request to conduct trials from Dr Shoukhrat Mitalipov of Oregon Health and Science University, who used a MR technique last year to create early human embryos (reported in BioNews 679) and in 2009 to create rhesus monkeys (reported in BioNews 523). The FDA began to regulate the techniques in 2001 as a form of gene therapy, reports Nature News, but had not until now received a request to conduct trials because of safety concerns, it said.

Dr Mitalipov now wants to conduct clinical trials of the techniques in humans and suggests that if the trial is not permitted, his team could continue the research outside the USA.

About one in 4,000 children in the USA will develop mitochondrial disease by the age of 10. In many cases, there is no cure or treatment and the disease can be fatal. But the techniques being developed to prevent the transmission of mitochondrial disease have also raised a variety of ethical and safety concerns (see BioNews 661).

When Dr Mitalipov used a MR technique last year to create early human embryos, genetic abnormalities were detected in half of them, Nature reported - although 20 percent of the eggs produced embryos that would have been suitable for transplantation, if permitted. Other safety concerns have been raised since then (reported in BioNews 723).

'If mistakes are made, if that child [is a girl and] has children down the line, those children will inherit the mitochondria from that child, and we'll have introduced new genetic diseases into the human population', said Professor Ronald Green, a bioethicist at Dartmouth College in New Hampshire.

However, Dr Mitalipov said last year that although the MR technique used needs further refinement, it is ready for the clinic. 'You can expect the first healthy child to be born [using this method] within three years', Nature reported him as saying at the time. He also points out that the rhesus monkeys are doing well, reported The Scientist.

The FDA was due to meet on 22 October to discuss these issues and to decide whether to permit the initial clinical trials, but the meeting has been postponed because of the recent government shutdown. The FDA published draft guidance on the design of early-phase clinical trials of cellular and gene therapy products in July this year, which it is scheduled to consider.

Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement
US Food and Drug Administration |  17 October 2013
FDA Considers Three-Parent IVF
The Scientist |  17 October 2013
Proposed Treatment To Fix Genetic Diseases Raises Ethical Issues
NPR Blog |  9 October 2013
Regulators weigh benefits of ‘three-parent’ fertilization
Nature News |  15 October 2013
17 March 2014 - by Dr Louisa Petchey 
The Conservative MP for North East Somerset, Jacob Rees-Mogg, has said that mitochondrial donation will produce 'genetically modified children' with 'three parents', and was 'effectively cloning'...
3 March 2014 - by Patricia Cassidy 
The UK Department of Health has published draft guidelines for the use of new techniques to prevent mothers passing on serious mitochondrial diseases to their children. The guidelines will be the subject of a three-month consultation...
3 March 2014 - by Chee Hoe Low 
The USA's Food and Drug Administration (FDA) is considering whether to allow human clinical trials of mitochondrial replacement, an IVF technique that uses gametes from three people...
2 December 2013 - by Dr John Appleby, Professor Rosamund Scott and Professor Stephen Wilkinson 
A group of European parliamentarians from the Council of Europe recently issued a declaration objecting to the HFEA's policy advice on experimental mitochondrial replacement therapy claiming that MRT is eugenic and inconsistent with human dignity. These are substantial moral claims, ones that deserve closer scrutiny, and it is an interesting and important exercise to consider how successful such arguments are...
14 October 2013 - by Dr Rosie Morley 
A group of European parliamentarians has criticised UK proposals to legislate for mitochondrial replacement therapy, calling it 'a eugenic practice'...
23 September 2013 - by Dr Rosie Morley 
A group of scientists has expressed concerns that it may be too soon to bring mitochondrial replacement techniques, which are still under development, to the clinic....
1 July 2013 - by Dr Rosie Morley 
The UK Government is to support the introduction of mitochondrial replacement therapy. The IVF-based procedure could allow women with mitochondrial disease the opportunity to have healthy children, by replacing their own, faulty, mitochondria with healthy mitochondria from a donor....
21 March 2013 - by Sandy Starr 
Mitochondrial replacement therapy, where a small amount of a mother's genetic material is swapped with material from a donor during IVF to avoid passing on heritable illnesses, enjoys the 'general support' of the public, the UK's fertility regulator says...
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