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Clinical investigations of MRT are ‘ethically permissible’ if conditions met

Conducting clinical investigations of mitochondrial replacement techniques (MRT) in humans is ethically permissible as long as significant conditions and principles are met, says a new report from the National Academies of Sciences, Engineering, and Medicine. One of those conditions, among many laid out in the report, is that initial MRT clinical investigations should be limited to women who are at risk of transmitting a severe mitochondrial genetic disease that could lead to a child’s early death or substantial impairment. Another is that in initial clinical investigations only male embryos created through MRT should be allowed to be placed in a woman for a possible pregnancy. The recommended restriction is predicated not on selection of one sex over another, but on the need to proceed carefully and to prevent potential adverse and uncertain consequences of MRT from being passed on to future generations. The committee that conducted the study and wrote the report stressed that when balancing the benefits and risks of MRT clinical investigations, the primary consideration is minimizing the risk of harm to the child born as a result of the techniques.

While not currently conducted in humans in the United States, mitochondrial replacement techniques hold the potential to significantly reduce the risk of transmitting serious and at times fatal mitochondrial DNA diseases from mother to child, but the techniques also raise many concerns. Mitochondria are found in almost every cell of the body and produce energy for cells. Mitochondrial disease, sometimes caused by mutations in mitochondrial DNA, occurs when the mitochondria fail to produce enough energy for cells or organs to function properly. All people have two types of DNA – nuclear DNA that encodes our traits and is found in the nucleus of a cell and mitochondrial DNA found in mitochondria. MRT would remove nuclear DNA from the egg of a woman affected by mitochondrial DNA disease and transfer it to an egg free of nuclear DNA provided by a woman with normal mitochondria. As mitochondria are inherited solely from the mother, this would, in theory, prevent transmission of mitochondrial DNA disease from the at-risk woman to her child. Children born as a result of MRT would have genetic material from three individuals: nuclear DNA from one man and one woman and mitochondrial DNA from another woman. The committee concluded that the combination of nuclear and mitochondrial DNA created by MRT results in heritable genetic modification, often termed germline modification. However, since mitochondrial DNA is only passed from women to their offspring, the genetic modification introduced by MRT would be heritable only in female children born through the process of MRT.

“In examining the ethical, social, and policy issues associated with mitochondrial replacement techniques, we concluded that the most germane issues could be avoided if the use of these techniques were restricted by certain conditions, rather than prohibiting them altogether,” said Jeffrey Kahn, chair of the committee and the Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy at The Johns Hopkins Berman Institute of Bioethics in Baltimore. “Although MRT would not treat a person with a mitochondrial disease, its pursuit could satisfy prospective parents’ desire to bear genetically related offspring with a significantly reduced risk of passing on mitochondrial disease. The limitations on MRT that we propose focus on protecting the health and well-being of children born as a result of the techniques.”