Mitochondrial disease affects about one in 200 children each year. This condition, which can greatly reduce quality of life and life expectancy of those affected, has no cure. But thanks to a recent ruling by the Human Fertilization and Embryology Authority (HFEA), the UK’s fertility watchdog, mitochondrial disease may eventually become a thing of the past.
In recent years, scientists have developed two techniques that can remove the faulty mitochondria (cell powerhouses responsible for energy, cell regeneration and more) from a mother’s egg. Donor mitochondria is then used to make the egg complete. In one technique, the mitochondria is removed and replaced prior to egg fertilization (spindle method). In the other, the process is done after fertilization.
Both have been done effectively in animals and in human embryos. In 2009, an Oregon team announced that they had produced three healthy rehesus macaques through the use of the spindle method. However, no healthy humans have yet been created with the use of either technique. Part of the wait has been due to the fact that there have been some abnormalities in about half of the human embryos made, which means that more testing needs to be done. But another part of the wait has had to do with waiting for an approval from the HFEA to move forward with clinical trials. Earlier this week, the HFEA gave that approval, stating there’s no scientific reason to not carry out replacement procedures once “further specific experiments” are conducted.
“In light of all the evidence received by the HFEA, I think the arguments for proceeding along the road to further the development and potential clinical application of the techniques are both clear and compelling,” Robin Lovell-Badge, head of stem cell biology and developmental genetics at the MRC National Institute for Medical Research and a member of the Oversight Committee for the Public Engagement and the panel that produced HFEA’s scientific, clinical and safety reports, told Wired.co.uk.
This finding was given, despite some controversy over whether or not allowing experiments to move forward would contradict any “ethical implications.” One of those implications would be the eventual production of “designer babies.” However, the HFEA has said that those arguments are irrelevant in the case of mitochondria replacement because the genetic alteration is purely directed at couples who would have passed along a terrible hereditary condition that could, ultimately, result in the death of their child.
“The fears expressed by some opponents of the techniques, such as that they will lead to ‘inexorably to the disaster of genetically engineered babies and consumer eugenics,’ have no grounding at all,” Lovell-Badge said. “The methods to achieve the latter are very different, we found no evidence that the public would show any support for these dubious (and currently unachievable) aims, and the distinction between both the aims and the methods required makes it very easy to have regulations and laws against their use.”
It was that same public opinion that helped sway the HFEA’s decision on whether or not clinical applications should be furthered in the area of mitochondrial replacement. Despite minority concerns, the general public showed support of the procedure. The public also showed a great deal of trust in the scientists that will continue to work on developing and tweaking the methods until they can be used in real human trials.
“Although some people have concerns about the safety of these techniques, we found that they trust the scientific experts and the regulator to know when it is appropriate to make them available to patients,” HFEA chair Lisa Jardine told Wired.co.uk.
Along with the approval to move forward, the HFEA passed on some specific recommendations to government ministers, who will have the final say in the matter. They recommended that all clinics who offer the mitochondria replacement, once success is achieved, be licensed by the HFEA to do so. Donors should be regarded as tissue donors so that they remain anonymous to all parties, and safety and efficacy trials should be carried out before any clinical proceedings begin. The HFEA also recommended that children born through the procedure (particularly in the beginning) should be given continued health care. The HFEA is also working at putting together some guidelines to ensure that no ethical or safety lines are crossed in the process.
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