Back in September, it was reported that spindle nuclear transfer was used to successfully transfer mitochondrial DNA into an egg in order to prevent a child from inheriting a mitochondrial disorder. The procedure was carried out in Mexico due to U.S. laws against it. Now, the FDA has warned the doctor behind this milestone to stop using the achievement in marketing materials for his fertility clinic:
The US Food and Drug Administration has told a New York fertility doctor to stop marketing a controversial three-parent fertility treatment, which makes it possible for babies to be made from two women and a man.
The health watchdog published a letter to Dr. John Zhang, founder of the New Hope Fertility Center in New York City, whose "spindle nuclear transfer" technique was used to conceive a boy born in Mexico in April 2016.
Zhang detailed the procedure in the journal Fertility and Sterility [open, DOI: 10.1016/j.fertnstert.2016.08.004] [DX] last year and is now marketing the technique, but the letter reminds Zhang the FDA has not authorized his use of the procedure in humans.
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A new mitochondrial donation technique called spindle nuclear transfer has been successfully used in order to prevent a child from inheriting a mitochondrial disorder:
It's not the first time scientists have created babies that have DNA from three people - that breakthrough began in the late 1990s - but it is an entirely new and significant method. [...] The US team, who travelled to Mexico to carry out the procedure because there are no laws there that prohibit it, used a method that takes all the vital DNA from the mother's egg plus healthy mitochondria from a donor egg to create a healthy new egg that can be fertilised with the father's sperm.
[...] Some have questioned whether we are only now hearing the success story while failed attempts could have gone unreported. Prof Alison Murdoch, part of the team at Newcastle University that has been at the forefront of three person IVF work in the UK, said: "The translation of mitochondrial donation to a clinical procedure is not a race but a goal to be achieved with caution to ensure both safety and reproducibility." Critics say the work is irresponsible. Dr David King from the pro-choice group Human Genetics Alert, said: "It is outrageous that they simply ignored the cautious approach of US regulators and went to Mexico, because they think they know better. Since when is a simplistic "to save lives is the ethical thing to do" a balanced medical ethics approach, especially when no lives were being saved?" Dr Zhang and his team say they will answer these questions when they presents[sic] their findings at a meeting of the American Society for Reproductive Medicine in October.
Also at The New York Times and NPR.
First live birth using human oocytes reconstituted by spindle nuclear transfer for mitochondrial DNA mutation causing Leigh syndrome (open, DOI: 10.1016/j.fertnstert.2016.08.004) (DX)
As far as I can tell, what you see in the above Fertility and Sterility paper is all that has been released.
Doctors have been given permission to create the UK's first "three-parent" or "three-person" babies to mitigate the risk of inheritable mitochondrial diseases:
Doctors have received permission to create the UK's first "three-person" babies for two women at risk of passing inheritable diseases to their children.
The two cases involve women who have mitochondrial diseases, which are passed down by the mother and can prove fatal.
Three-person babies involve an advanced form of IVF that uses a donor egg, the mother's egg and the father's sperm.
Doctors at the Newcastle Fertility Centre will carry out the procedure.
The decision was approved by the UK Fertility Regulator, the Human Fertilisation and Embryology Authority (HFEA).
Also at New Scientist.
Previously: Mitochondrial DNA Manipulation and Ethics
Approval for Three-Parent Embryo Trials
Fatal Genetic Conditions Could Return in Some 'Three-Parent' Babies
Baby Girl Born in Ukraine Using Three-Parent Pronuclear Transfer Technique
FDA Warns Doctor Against Marketing Three-Person IVF Technique
Related: First Human Embryo Editing Performed in the UK
Mitochondrial donation treatment aims to prevent children from inheriting incurable diseases:
The first UK baby created with DNA from three people has been born after doctors performed a groundbreaking IVF procedure that aims to prevent children from inheriting incurable diseases.
The technique, known as mitochondrial donation treatment (MDT), uses tissue from the eggs of healthy female donors to create IVF embryos that are free from harmful mutations their mothers carry and are likely to pass on to their children.
Because the embryos combine sperm and egg from the biological parents with tiny battery-like structures called mitochondria from the donor's egg, the resulting baby has DNA from the mother and father as usual, plus a small amount of genetic material – about 37 genes – from the donor.
The process has led to the phrase "three-parent babies", though more than 99.8% of the DNA in the babies comes from the mother and father.
Research on MDT, which is also known as mitochondrial replacement therapy (MRT), was pioneered in the UK by doctors at the Newcastle Fertility Centre. The work aimed to help women with mutated mitochondria to have babies without the risk of passing on genetic disorders. People inherit all their mitochondria from their mother, so harmful mutations in the "batteries" can affect all of the children a woman has.
[...] The Newcastle process has several steps. First, sperm from the father is used to fertilise eggs from the affected mother and a healthy female donor. The nuclear genetic material from the donor's egg is then removed and replaced with that from the couple's fertilised egg. The resulting egg has a full set of chromosomes from both parents, but carries the donor's healthy mitochondria instead of the mother's faulty ones. This is then implanted in the womb.
(Score: 1, Informative) by Anonymous Coward on Wednesday August 09 2017, @12:35PM (1 child)
This appears to be about some kind of Obama era political thing rather than safety concerns:
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM570225.pdf [fda.gov]
Looks like some of the babies mitochondria still do have the mutation, but it is a much smaller percent than her earlier children:
http://www.fertstert.org/article/S0015-0282%2816%2962670-5/fulltext [fertstert.org]
If the other child lived to 6 yrs old though it may be wise to see what happens here. If the baby was at least 3 months old last September it is over a year old now. Any update on that?
(Score: 3, Interesting) by EvilSS on Wednesday August 09 2017, @05:12PM