FDA considers allowing human studies on '3-parent' embryos

U.S. medical advisers are looking for scientific justification for allowing human studies of a procedure known as "three-parent in vitro fertilization (IVF)," a technique supporters say could prevent horrific genetic defects, Fox News reports.

During two days of public hearings starting on Tuesday, scientists were scheduled to present their research to outside advisers to the U.S. Food and Drug Administration. The agency will decide whether safety concerns raised by three-parent IVF are minimal enough to allow clinical trials to begin.

In the three-parent procedure, one man would donate sperm and all its DNA for in-vitro fertilization. The would-be biological mother would contribute the egg and most of its DNA. But if the mother carries harmful genetic mutations in cellular structures called mitochondria, scientists would remove her unhealthy mitochondria and substitute those of a second woman so the baby would not inherit a potentially devastating "mitochondrial disease."

Allowing such procedures "would produce genetically modified human beings," Marcy Darnovsky, executive director of the Berkeley, California-based Center for Genetics and Society, told the committee.

Another technique, called maternal spindle transfer, starts with an unfertilized egg from a woman with mitochondrial mutations, explained  biologist Shoukhrat Mitalipov of Oregon Health and Science University, who has used the technique in monkeys and has raised five healthy monkeys that were originally destined for genetic diseases. He said the technique is ready for human trials. The egg's genome is removed and injected into a healthy egg whose own genome has been removed. The egg, with standard DNA from the mother-to-be and mitochondrial DNA from the egg donor, is then fertilized with the would-be father's sperm.

The FDA has authority over any clinical trials of mitochondrial manipulation as part of its mandate to protect human research subjects, which in this case includes women and any children born from the procedure.

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