Mitochondrial Replacement Techniques Ethical, Social, and Policy Considerations (2016) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-26
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From page 17... ...
. The oral comments received by FDA from members of the public at this meeting revealed substantial concern among certain commenters about the perceived ethical, social, and policy implications of the proposed techniques, which entailed issues outside the scope of the advisory committee's discussion.
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From page 18... ...
These include maternal spindle transfer, pronuclear transfer, and polar body transfer but could also encompass other technologies not currently proposed. The development of novel techniques in this area raises complex ethical and social policy issues, including • W hether manipulation of mitochondrial content should be considered germline modification (defined as human inheritable genetic modification)
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From page 19... ...
dividual inherits a pathogenic nuclear DNA (nDNA) mutation from one or both parents that affects mitochondrial function; or an individual develops a de novo pathogenic mutation in either mtDNA or nDNA that affects mitochondrial function.
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From page 20... ...
technique that involves removing an intended mother's nDNA from her oocyte or zygote, which contains mutated mtDNA, and transferring it into a female provider's oocyte or zygote, which contains nonpathogenic mtDNA and from which the nDNA has been removed.2 The woman providing oocytes would have no personal or family history or genetic evidence of having mutated, pathogenic mtDNA. In this report, the term "MRT" encompasses both the transfer of the nuclear genetic material and the accompanying fertilization procedure that is necessary to produce a human embryo.
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From page 21... ...
Following fertilization, the embryo would be grown in culture and subjected to diagnostic testing to ensure its quality and viability; the testing would include preimplantation genetic diagnosis (PGD) to confirm that the embryo had acceptably low or undetectable levels of the pathogenic mtDNA molecules.
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From page 22... ...
It has recently has been shown to effectively reduce heteroplasmy levels and prevent transmission of pathogenic mtDNA in mouse and mammalian oocytes and one-cell embryos. As a result, heteroplasmy shift has been proposed as an alternative to MRT for preventing maternal transmission of pathogenic mtDNA mutations that precludes the need for the contribution of a second woman's genetic material (Reddy et al., 2015)
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From page 23... ...
The HFEA's Ethics and Law Advisory Committee considered the ethical issues surrounding MRT, and the HFEA consulted and engaged in dialogue with the public through public workshops, surveys, and focus groups. In early 2014, the UK Department of Health released draft regulations for public review, and in early 2015, Parliament considered and approved revised regulations.
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From page 24... ...
Chapter 2, "Science and Policy Context," presents an overview of reproductive medicine, mitochondrial biology, and mtDNA diseases; a review of the MRT research conducted to date; and discussion of the potential risks associated with MRT, as well as the policy context surrounding potential human clinical investigations in and clinical applications of MRT. Chapter 3, "Do Ethical, Social, and Policy Considerations Preclude MRT?
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From page 25... ...
. FDA Cellular Tissue and Gene Therapies Advisory Committee.
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