Researchers with the National Academy of Science have laid out standards and conditions to be met prior to green-lighting clinical investigations of mitochondrial replacement techniques. Photo by nevodka/Shutterstock.com
WASHINGTON, Feb. 3 (UPI) -- In a news release issued Wednesday, medical researchers laid out ethical standards for clinical investigations into mitochondrial replacement therapy, or MRT.
MRT is "ethically permissible" only when "significant conditions and principles are met," according to a new report from the National Academies of Sciences, Engineering, and Medicine.
Human MRT is not currently conducted in the United States, but the technology holds promise. The therapy involves the removal of nuclear DNA from the egg of a woman who is at risk of passing a mitochondrial DNA disease onto her child. The nuclear DNA is the transferred to a nuclear DNA-free egg provided by a woman with healthy healthy mitochondria. The resulting egg would have genetic material from two women.
The new report: "http://www.nap.edu/catalog/21871/mitochondrial-replacement-techniques-ethical-social-and-policy-considerations" target="_blank"} suggests the FDA only review MRT clinical trials for women at risk of passing on a serious mitochondrial disease. Because mitochondrial DNA can only be passed on through the mother, researchers with the National Academies also recommend that only male embryos be implanted during initial clinical investigations to prevent heritability of changes.
"FDA could consider extending MRT research to include the transfer of female embryos if clear evidence of safety and efficacy from male cohorts using identical MRT procedures is available," researchers wrote.
Furthermore, the report recommends that only research clinics with "demonstrated expertise" be approved for such investigations -- and only after exhausting pretrial research options with in vitro tests, animal, and human embryos, nonviable whenever possible.
Researchers say strong standards need to be in place, as the stakes are high.
"The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible," researchers wrote in their report.