Academy of Medical Sciences (2011). Animals containing human material. http://www.acmedsci.ac.uk/policy/policy-projects/animals-containing-human-material/

American College of Obstetricians and Gynecologists (2006). Using preimplantation embryos for research. ACOG Committee Opinion No. 347. Obstet. Gynecol. 108, 13051317.

Bacman, S., Williams, S., Pinto, M. et al. Specific elimination of mutant mitochondrial genomes in patient-derived cells by mitoTALENs. Nat Med 19, 11111113 (2013). https://doi.org/10.1038/nm.3261

Bacman SR, Kauppila JHK, Pereira CV, et al. MitoTALEN reduces mutant mtDNA load and restores tRNAAla levels in a mouse model of heteroplasmic mtDNA mutation [published correction appears in Nat Med. 2018 Oct 5;:]. Nat Med. 2018;24(11):16961700. doi:10.1038/s41591-018-0166-8

Benjaminy S, Kowal SP, MacDonald IM, Bubela T. Communicating the promise for ocular gene therapies: challenges and recommendations. Am J Ophthalmol. 2015 Sep;160(3):408-415.e2. doi: 10.1016/j.ajo.2015.05.026. Epub 2015 May 30. PMID: 26032192.

Boer, G. J. (1994). Ethical guidelines for the use of human embryonic or fetal tissue for experimental and clinical neurotransplantation and research. Journal of Neurology 242, 113.

Boutron, I., Dutton, S., Ravaud, P., and Altman, D.G. (2010). Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 303, 2058-2064.

Bubela T, McCabe C, Archibald P, Atkins H, Bradshaw SE, Kefalas P, Mujoomdar M, Packer C, Piret J, Raxworthy M, Soares M, Viswanathan S. Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. Regen Med. 2015;10(7):897-911. doi: 10.2217/rme.15.51. Epub 2015 Nov 13. PMID: 26565607.

Camacho, L.H., Bacik, J., Cheung, A., and Spriggs, D.R. (2005). Presentation and subsequent publication rates of phase I oncology clinical trials. Cancer 104, 1497-1504.

Costa-Borges, N., Nikitos, E., Spath, K. et al. (2020) First registered pilot trial to validate the safety and effectiveness of maternal spindle transfer to overcome infertility associated with poor oocyte quality. Fertility & Sterility (Abstract only) 114, issue 3, supplement , e71-e72 https://doi.org/10.1016/j.fertnstert.2020.08.220

Council for International Organizations of Medical Sciences (2016). International Ethical Guidelines for Health-related Research Involving Humans. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

Department of Health, and Education and Welfare (1979). Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (The Belmont Report). 44 Fed. Reg. 23, 192.

ESHRE Taskforce on Ethics and Law (2001). The moral status of the pre-implantation embryo. Hum. Reprod. 17, 1409-1419.

Easson EC, Russell MH. Cure of Hodgkins disease. BMJ. 1963;5347:17047.

Ethics Committee of American Society for Reproductive Medicine (2013). Donating embryos for human embryonic stem cell (hESC) research: a committee opinion. Fertil. Steril. 100, 935-939.

European Parliament and Council of the European Union (2001). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (Official Journal of the European Union).

European Science Foundation (2000). Good scientific practice in research and scholarship. Science Policy Briefing. http://www.esf.org/fileadmin/Public_documents/Publications/ESPB10.pdf

Fisher, M., Feuerstein, G., Howells, D.W., Hurn, P.D., Kent, T.A., Savitz, S.I., and Lo, E.H. (2009). Update of the stroke therapy academic industry roundtable preclinical recommendations. Stroke 40, 2244-2250.

Flory, J., and Emanuel, E. (2004). Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 292, 1593-1601.

Food and Drug Administration (2017). FDA Announces Comprehensive Regenerative Medicine Policy Framework. https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework

Freeman, G.A., and Kimmelman, J. (2012). Publication and reporting conduct for pharmacodynamic analyses of tumor tissue in early-phase oncology trials. Clinical Cancer Research 18, 6478-6484.

Frei, E. 3rd & Gehan, E. A. Definition of cure for Hodgkins disease. Cancer Res. 31, 18281833 (1971).

Fung M, Yuan Y, Atkins H, Shi Q, Bubela T. Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications. Stem Cell Reports. 2017 May 9;8(5):1190-1201. doi: 10.1016/j.stemcr.2017.03.013. Epub 2017 Apr 13. PMID: 28416287; PMCID: PMC5425617.

Haimes, E., Skene, L., Ballantyne, A.J., Caulfield, T., Goldstein, L.S., Hyun, I., Kimmelman, J., Robert, J.S., Roxland, B.E., Scott, C.T., et al. (2013). Position statement on the provision and procurement of human eggs for stem cell research. Cell Stem Cell 12, 285-291.

Henderson, V.C., Kimmelman, J., Fergusson, D., Grimshaw, J.M., and Hackam, D.G. (2013). Threats to validity in the design and conduct of preclinical efficacy studies: a systematic review of guidelines for in vivo animal experiments. PLoS Medicine 10, e1001489.

Hudson, G., Takeda, Y. & Herbert, M. Reversion after replacement of mitochondrial DNA. Nature 574, E8E11 (2019). https://doi.org/10.1038/s41586-019-1623-3

Human Fertilization and Embryology Authority (2016). Scientific review of the safety and efficacy of methods to avoid mitochondrial disease through assisted conception: 2016 update. https://www.hfea.gov.uk/media/2611/fourth_scientific_review_mitochondria_2016.pdf

Human Fertilization and Embryology Authority (2019). Code of Practice, 9th Edition. https://portal.hfea.gov.uk/media/1527/2019-12-16-code-of-practice-9th-edition-december-2019.pdf

Hyslop LA, Blakeley P, Craven L, Richardson J, Fogarty NM, Fragouli E, Lamb M, Wamaitha SE, Prathalingam N, Zhang Q, OKeefe H. Towards clinical application of pronuclear transfer to prevent mitochondrial DNA disease. Nature. 2016 Jun 8 534: 383-386.

Hyun, I. (2013). Therapeutic hope, spiritual distress, and the problem of stem cell tourism. Cell Stem Cell12, 505-507.

Hyun, I., Taylor, P., Testa, G., Dickens, B., Jung, K. W., McNab, A., Roberston, J., Skene, L., and Zoloth, L. (2007). Ethical standards for human-to-animal chimera experiments in stem cell research. Cell Stem Cell 1, 159163.

International Society for Stem Cell Research (ISSCR). (2006). Guidelines for the conduct of human embryonic stem cell research. http://www.isscr.org/docs/default-source/hesc-guidelines/isscrhescguidelines2006.pdf.

International Society for Stem Cell Research (ISSCR). (2008). Guidelines for the clinical translation of stem cells. http://www.isscr.org/docs/default-source/clin-trans-guidelines/isscrglclinicaltrans.pdf.

International Society for Stem Cell Research (ISSCR). (2016). Guidelines for Stem Cell Research and Clinical Translation. https://www.isscr.org/docs/default-source/all-isscr-guidelines/guidelines-2016/isscr-guidelines-for-stem-cell-research-and-clinical-translationd67119731dff6ddbb37cff0000940c19.pdf?sfvrsn=4

Madan K. Natural human chimeras: A review. Eur J Med Genet. 2020 Sep;63(9):103971. doi: 10.1016/j.ejmg.2020.103971. Epub 2020 Jun 18. PMID: 32565253.

National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2009. On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition. Washington, DC: The National Academies Press. https://doi.org/10.17226/12192.

National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC.: The National Academies Press. doi: 10.17226/25665.

Institute of Medicine (2015). Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks (Washington, DC: National Academies Press). doi:10.17226/18998.

Nuffield Council on Bioethics. 2016. Genome Editing: An Ethical Review. https://www.nuffieldbioethics.org/wp-content/uploads/Genome-editing-an-ethical-review.pdf

Institute of Medicine and National Research Council. 2010. Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. https://doi.org/10.17226/12923.

Kamenova, K., and Caulfield, T. (2015). Stem cell hype: media portrayal of therapy translation. Science Translational Medicine 7, 278ps274.

Kang, E., Koski, A., Amato, P. et al. Reply to: Reversion after replacement of mitochondrial DNA. Nature 574, E12E13 (2019). https://doi.org/10.1038/s41586-019-1624-2

Kang E, Wu J, Gutierrez NM, Koski A, Tippner-Hedges R, Agaronyan K, Platero-Luengo A, Martinez-Redondo P, Ma H, Lee Y, Hayama T, Van Dyken C, Wang X, Luo S, Ahmed R, Li Y, Ji D, Kayali R, Cinnioglu C, Olson S, Jensen J, Battaglia D, Lee D, Wu D, Huang T, Wolf DP, Temiakov D, Izpisua Belmonte JC, Amato P, Mitalipov S. Mitochondrial replacement in human oocytes carrying pathogenic mitochondrial DNA mutations. Nature 2016 DOI: 10.1038/nature20592

Kilkenny C, Browne WJ, Cuthill IC, Emerson M, and Altman DG (2010). Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. Plos Biol 8, e1000412.

Kimmelman, J., Mogil, J.S., Dirnagl, U. (2014). Distinguishing between Exploratory and Confirmatory Preclinical Research Will Improve Translation. PLoS Biol. 12, e1001863.

Kuriyan AE, Albini TA, Townsend JH, et al. Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD. N Engl J Med. 2017; 376(11):10471053. doi:10.1056/NEJMoa1609583

Landis, S.C., Amara, S.G., Asadullah, K., Austin, C.P., Blumenstein, R., Bradley, E.W., Crystal, R.G., Darnell, R.B., Ferrante, R.J., Fillit, H., et al. (2012). A call for transparent reporting to optimize the predictive value of preclinical research. Nature 490, 187-191.

Lau, D., Ogbogu, U., Taylor, B., Stafinski, T., Menon, D., and Caulfield, T. (2008). Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell 3, 591-594.

Mazur, P et al. 2019 P-221 Mitochondrial Replacement Therapy Gives No Benefits to Patients of Advanced Maternal Age. Paper presented to ASRM Scientific Conference and Expo, Philadelphia, Oct. 14-16. https://asrm.confex.com/asrm/2019/meetingapp.cgi/Paper/2347

Medical Professionalism Project (2002). Medical professionalism in the new millennium: a physician charter. Annals of Internal medicine 136, 243-246.

Munsie, M., and Hyun, I. (2014). A question of ethics: selling autologous stem cell therapies flaunts professional standards. Stem Cell Research 13, 647-653.

National Academies of Sciences, Engineering, and Medicine (2016). Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. (Washington, DC: The National Academies Press). doi:10.17226/21871.

National Institutes of Health (2014). Informed Consent Guidance for Human Gene Trials subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Office of Science Policy: Office of Biotechnology Activities). http://osp.od.nih.gov/sites/default/files/resources/IC2013.pdf

Nissanka N, Moraes CT. Mitochondrial DNA heteroplasmy in disease and targeted nuclease-based therapeutic approaches. EMBO Rep. 2020;21(3):e49612. doi:10.15252/embr.201949612

Nuremberg Code (1949). In Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No 10, Vol 2 (Washington, DC: U.S. Government Printing Office), pp 181-182.

Office for Human Research Protections (OHRP) (1993). Research on Transplantation of Fetal Tissue SEC. 498A, National Institutes of Health Revitalization Act of 1993. http://www.hhs.gov/ohrp/policy/publiclaw103-43.htm.html

Percie du Sert N, Hurst V, Ahluwalia A, Alam S, Avey MT, Baker M, et al. (2020) The ARRIVE guidelines 2.0: Updated guidelines for reporting animal research. PLoS Biol 18(7): e3000410. https://doi.org/10.1371/journal.pbio.3000410

Ravi, P., Kumar, S.K., Cerhan, J.R. et al. Defining cure in multiple myeloma: a comparative study of outcomes of young individuals with myeloma and curable hematologic malignancies. Blood Cancer Journal 8, 26 (2018). https://doi.org/10.1038/s41408-018-0065-8:

Reddy, Pradeep et al. Selective Elimination of Mitochondrial Mutations in the Germline by Genome Editing. Cell, Volume 161, Issue 3 (2015) pp. 459 469. https://doi.org/10.1016/j.cell.2015.03.051

Saini, P., Loke, Y.K., Gamble, C., Altman, D.G., Williamson, P.R., and Kirkham, J.J. (2014). Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ 349, g6501.

SB-180 Gene therapy kits: advisory notice and labels.(2019-2020). California State Legislature.

S.D. Tardif, K. Coleman, T.R. Hobbs, C. Lutz, IACUC Review of Nonhuman Primate Research, ILAR Journal 53, no. 2, 2013: DOI: 10.1093/ilar/ilt040.

Sena, E.S., van der Worp, H.B., Bath, P.M., Howells, D.W., and Macleod, M.R. (2010). Publication bias in reports of animal stroke studies leads to major overstatement of efficacy. PLoS Biol. 8, e1000344.

Sugarman J, Siegel A. How to determine whether existing human embryonic stem cell lines can be used ethically. Cell Stem Cell 2008; 3: 238-9. PMID: 18786411.

Sugarman J, Siegel AW. When embryonic stem cell lines fail to meet consent standards. Science 2008; 322: 379. PMID: 18927375.

Tsilidis, K.K., Panagiotou, O.A., Sena, E.S., Aretouli, E., Evangelou, E., Howells, D.W., Al-Shahi Salman. R., Macleod, M.R., Ioannidis, J.P. (2013). Evaluation of excess significance bias in animal studies of neurological diseases. PLoS Biol. 11, e1001609.

U.K. Department of Health (2014). Mitochondrial donation. Government response to the consultation on draft regulations to permit the use of new treatment techniques to prevent the transmission of a serious mitochondrial disease from mother to child. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/332881/Consultation_response.pdf

Wang, Tian et al. Polar Body Genome Transfer for Preventing the Transmission of Inherited Mitochondrial Diseases. Cell, 157 (2014), pp. 1591-1604. https://doi.org/10.1016/j.cell.2014.04.042

World Medical Association (2018). Declaration of Helsinki: Ethical principles for medical research involving human subjects. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Wu, K., Zhong, C., Chen, T. et al. Polar bodies are efficient donors for reconstruction of human embryos for potential mitochondrial replacement therapy. Cell Res 27, 10691072 (2017). https://doi.org/10.1038/cr.2017.67

Yamada M, Emmanuele V, Sanchez-Quintero MJ, Sun B, Lallos G, Paull D, Zimmer M, Pagett S, Prosser RW, Sauer MV, Hirano M. Genetic Drift Can Compromise Mitochondrial Replacement by Nuclear Transfer in Human Oocytes. Cell stem cell. 2016 Jun 2;18(6):749-54.

Zhang, John et al. Pregnancy derived from human zygote pronuclear transfer in a patient who had arrested embryos after IVF. Reproductive biomedicine online vol. 33,4 (2016): 529-533. doi:10.1016/j.rbmo.2016.07.008

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