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# FDA-sponsored Report on Mitochondrial Replacement Techniques
- URL: https://www.fdaweb.com/fda-sponsored-report-on-mitochondrial-replacement-techniques/
- Published: 2016-02-03T12:00:00.000Z
- Updated: 2026-09-15T02:33:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134672

> An FDA-sponsored [report](http://nationalacademies.us8.list-manage.com/track/click?u=ab74d126b7d2db12591de5c2c&id=12e2f3f0d6&e=4b08129e1e&ref=fdaweb.com) by the Institute of Medicine recommends that the agency allow sponsors to conduct initial mitochondrial replacement technique (MRT) clinical investigations only when several conditions are met. These include limiting clinical investigations to women who are at risk of passing on a serious mitochondrial disease to their offspring, where the mitochondrial DNA’s mutation is known to cause disease, and clinical presentation of the disease is predicted to be severe by causing early death or substantial impairment in the child.  
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> According to the report, MRTs are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. “The goal of MRT is to prevent the transmission of these serious diseases by creating an embryo with nuclear DNA (nDNA) from the intended mother and mtDNA from a woman with nonpathogenic mtDNA through modification of either an oocyte (egg) or zygote (fertilized egg),” it says. Two techniques were considered by the committee – maternal spindle transfer which involves oocyte manipulation and pronuclear transfer that involves zygote manipulation of zygotes. “If effective,” the report says, “MRT could satisfy the desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, yet the techniques raise ethical, social, and policy issues.”  
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> Another report recommendation is that initial clinical investigations use only male embryos created through MRT and placed in a woman for a possible pregnancy. By transferring only male embryos for gestation, it would avoid introducing “heritable genetic modification during initial clinical investigations,” it says.  
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> If the initial investigations of MRT in male embryos is successful, the report says FDA could consider extending the research to include the transfer of female embryos if clear evidence of safety and efficacy from male cohorts using identical MRT procedures is available. “In addition, preclinical research in animals has to show evidence of intergenerational safety and efficacy, and FDA’s decision should be consistent with the outcome of public and scientific deliberations to establish a shared framework concerning the acceptability of and moral limits on heritable genetic modification,” it says.  
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> Additional conditions for initial MRT clinical investigations that the report recommended are:  
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> · initial safety is established and risks to all parties directly involved in the proposed clinical investigations are minimized, although minimizing risk to future children should be of highest priority;  
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> · the likelihood of efficacy is established by preclinical research using *in vitro* modeling, animal testing, and testing on human embryos as necessary;  
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> · if the intended mother at risk of transmitting mitochondrial disease also desires to carry the pregnancy, it is determined by professional opinion that she is able to complete a pregnancy without significant risk of serious adverse consequences to her health or the health of the fetus;  
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> · clinical investigations are limited to investigators and centers with demonstrated expertise in and skill with the relevant techniques; and  
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> · FDA has reviewed the science surrounding matching the mitochondrial DNA subtype of the egg provider with that of the intended mother and if compelling, has considered such matching as a means of mitigating the possible risk of incompatibility that could arise from combining the egg provider’s mitochondrial DNA with the nuclear DNA of the intended mother.