Potentially, the procedure may cut off mitochondrial diseases that are passed down through females and occur in about 1 in 4,000 people. One example is Melas syndrome, which causes a person to have continuing small strokes that damage their brains, leading to vision loss, problems with movement, dementia and death, according to the National Institutes of Health.
“What the FDA needs to think about is that this isn’t a procedure to repair mitochondrial disease,” said Vamsi Mootha, a professor of systems biology and medicine at Harvard Medical School inBoston who studies mitochondrial disorders. “It’s designed to prevent disease. It’s designed to offer a woman who’s a carrier for disease more options.”
Shoukhrat Mitalipov, the researcher heading the Oregon team’s work, declined to comment before the FDA meeting.
Monkey Research
In early research, four macaque monkeys were born from the procedure, according to a 2009 report by the Oregon researchers in the journal Nature. They were reported as healthy at age 3.
In October 2017, Nature published reports that the technique had also been used in human egg cells. The resulting embryos were allowed to develop to the blastocyst stage, which usually occurs about five days after fertilization.
About half of the egg cells displayed normal development, the scientists found. Though the procedure is legal in the laboratory, the embryos that result from it can’t be implanted in women without the FDA’s consent, leading to today’s session.
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