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Shoukhrat Mitalipov, Ph.D., whose research group at the Oregon Stem Cell Center at OHSU has tested the technology in macaque monkeys, said that their research cohort currently includes four subjects born through mitochondrial manipulation that are almost adults. To date, they have been healthy, with normal blood test results, and are no different from controls, showing that mitochondrial DNA in oocytes can be replaced.
The next step in their research is to recruit families who are carriers of early-onset mitochondrial DNA diseases who have had at least one affected child, recruit healthy egg donors, and then perform the procedure, followed by preimplantation genetic diagnosis of the embryo and/or prenatal diagnosis to "ensure complete mitochondrial DNA replacement and chromosomal normalcy," he said.
The panel was also asked to discuss the use of mitochondrial manipulation as a treatment for infertility. However, members considered this indication a far different type of application than preventing mitochondrial disease, which would have different inclusion criteria, controls, and risk-benefit evaluations, and several panelists raised particular concerns about the use of this technology for infertility.
"The idea we’re going to do anything to infertility patients involving mitochondria I think should be off the table," Dr. Keefe said, noting that there is "a very, very slippery slope when you’re dealing with human reproduction" in the United States, where licensure of infertility clinics is not required.
The controversies of this area of research, which some critics point out would result in a child with three genetically related parents, were not off limits to the open public hearing speakers, including Marcy Darnovsky, Ph.D., executive director of the Center for Genetics and Society.
"We want to avoid waking up in a world" where researchers, infertility clinics, governments, insurance companies, "or parents decide that they are going to try to engineer children with specific traits and even possibly [put] in motion a regime of high-tech consumer eugenics," she said.