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Response: First birth following spindle transfer

      In a letter in this issue of RBMOnline,
      • Gleicher N.
      • Kushnir V.A.
      • Albertini D.A.
      • Barad D.A.
      First birth following spindle transfer.
      criticize a paper describing the birth of the first mitochondrial replacement therapy (MRT) baby (
      • Zhang J.
      • Liu H.
      • Luo S.
      • Lu Z.
      • Chávez-Badiola A.
      • Liu Z.
      • Yang M.
      • Merhi Z.
      • Silber S.J.
      • Munné S.
      • Konstandinidis M.
      • Wells D.
      • Tan J.J.
      • Huang T.
      Live birth derived from oocyte spindle transfer to prevent mitochondrial disease.
      ) and debate the views expressed in the accompanying editorial (
      • Alikani M.
      • Fauser B.C.J.
      • García-Valesco J.A.
      • Simpson J.L.
      • Johnson M.H.
      First birth following spindle transfer for mitochondrial replacement therapy: hope and trepidation.
      ). Here, we offer a point of discussion related to the argument of legality posed by Dr Gleicher and colleagues. Regarding the now-published details of the location of (i) IVF, egg donation and MRT procedures in New York City, (ii) blastocyst vitrification and biopsy in New York City, (iii) cryopreserved embryo transport from the USA to Mexico and (iv) embryo transfer to the patient in Dr Zhang's New Hope Clinic in Mexico, the argument is made by Gleicher and colleagues that this ‘clearly established intent to breach FDA guidelines’. We would like to elaborate, as the authors of the letter appear misinformed about the USA Food and Drug Administration (FDA) guidelines in this area of research.
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      References

        • Alikani M.
        • Fauser B.C.J.
        • García-Valesco J.A.
        • Simpson J.L.
        • Johnson M.H.
        First birth following spindle transfer for mitochondrial replacement therapy: hope and trepidation.
        Reprod. Biomed. Online. 2017; 34: 333-336
        • Gleicher N.
        • Kushnir V.A.
        • Albertini D.A.
        • Barad D.A.
        First birth following spindle transfer.
        Reprod. Biomed. Online. 2017; 35: 542-543
        • Zhang J.
        • Liu H.
        • Luo S.
        • Lu Z.
        • Chávez-Badiola A.
        • Liu Z.
        • Yang M.
        • Merhi Z.
        • Silber S.J.
        • Munné S.
        • Konstandinidis M.
        • Wells D.
        • Tan J.J.
        • Huang T.
        Live birth derived from oocyte spindle transfer to prevent mitochondrial disease.
        Reprod. Biomed. Online. 2017; 34: 361-368