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The Fertility Show


 

Panel recommends FDA approval of mitochondrial donation

08 February 2016

By Kirsty Oswald

Appeared in BioNews 838

Clinical investigations of mitochondrial donation are 'ethically permissable', says a panel of experts reporting to the US Food and Drug Administration (FDA).

But the committee said that a strict set of conditions must be met if mitochondrial donation is to proceed, to enable a cautious and risk-limiting approach. This includes a potentially contentious recommendation that mitochondrial donation should initially be restricted to male embryos only.

The conclusions are part of a report by a 12-person committee convened by the National Academy of Sciences, Engineering, and Medicine. The panel was requested by the FDA to weigh up the ethical considerations of mitochondrial donation after it received two applications from groups wanting to conduct research using the technique.

The report, which is summarised in Science, says that, initially, mitochondrial donation should only be used for women who risk passing on serious forms of mitochondrial disease that would result in severe disability or early death in their offspring.

As mitochondrial donation results in changes to DNA that would be inherited from female to female, it also recommends limiting the technique to male embryos initially. Research into the intergenerational effects of mitochondrial donation could continue to be assessed while allowing some families affected by mitochondrial disease to have male children, the committee suggest.

They insist that this does not amount to sex selection but is based on 'the need to proceed slowly and to prevent potential adverse and uncertain consequences of MRT from being passed on to future generations'.

In future, female children could be born using the technique, contingent upon adequate follow-up of male children and satisfactory findings on the intergenerational effects from animal studies.

'Minimising risk to future children should be of highest priority,' the committee writes.

Mitochondrial donation is intended to prevent the transmission of faulty mitochondria from mother to child using healthy mitochondria from a donor egg. This results in the creation of embryos that have genetic material from three people, as the mitochondria contain their own DNA.

Last year, the UK approved regulations allowing licensed use of the technique, and is currently the only country to do so (see BioNews 789). However, it remains unclear if the USA will follow suit.

Although the FDA said it would be 'reviewing' the recommendations, its hands are currently tied by the latest federal budget which prevents it from spending funds to evaluate applications for research or clinical applications that involve implanting modified embryos into a woman (see BioNews 809). According to Nature, the FDA has confirmed that this includes embryos created via mitochondrial donation.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

03 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...
28 September 2016 - by César Palacios González 
Dr John Zhang's team have opened a new door in terms of reproductive possibilities, but they may very well be instrumental in closing the assisted reproductive door for many people in Mexico...
22 August 2016 - by Dr Özge Özkaya 
Chinese researchers say an IVF technique called pronuclear transfer can safely produce a viable pregnancy...
18 July 2016 - by Dr Dusko Ilic 
A match of mitochondrial and nuclear genomes apparently affects healthy ageing in mice. But key questions need to be answered before stirring up implications for human mitochondrial replacement therapies...
13 June 2016 - by Dr Özge Özkaya 
An extensive study examining human embryos created using mitochondrial donation has demonstrated that the technique does not adversely affect embryo development...

11 January 2016 - by Dr Cathy Herbrand 
We report from the second session of the annual conference of the Progress Educational Trust, titled 'From Three-Person IVF to Genome Editing: the Science and the Ethics of Engineering the Embryo', about the newly legalised process of mitochondrial donation...
02 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...
06 July 2015 - by Cait McDonagh 
The US Congress has released a bill that would prohibit the Food and Drug Administration from spending any money in relation to projects that involve editing the human genome...
05 May 2015 - by Ayala Ochert 
The US National Institutes of Health has issued a firm statement that it will not fund any research involving gene-editing technologies in human embryos...
03 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...

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