Mansour AA, Gonçalves JT, Bloyd CW, Li H, Fernandes S, Quang D, et al. An in vivo model of functional and vascularized human brain organoids. Nat Biotechnol. 2018;36(5):432–41.
Google Scholar
https://www.tmd.ac.jp/press-release/20220707-1/. 2022.
National Acadamy of Sciences. Guidelines for human embryonic stem cell research. Washington, D.C.; 2005.
National Acadamy of Sciences. The emerging field of human neural organoids, transplants, and chimeras. The emerging field of human neural Organoids, transplants, and chimeras; 2021.
Directorate-General for Health and Food Safety, European Commission. Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC. Brussels; 2022.
European Parliament and the Council of the European Union. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, Vol. L. Brussels: Official Journal of the European Union; 2007.
Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007;131(5):861–72.
Google Scholar
Oksdath M, Perrin SL, Bardy C, Hilder EF, DeForest CA, Arrua RD, et al. Review: synthetic scaffolds to control the biochemical, mechanical, and geometrical environment of stem cell-derived brain organoids. APL Bioeng. 2018;2(4):41501.
Google Scholar
Garreta E, Kamm RD, de Sousa C, Lopes SM, Lancaster MA, Weiss R, et al. Rethinking organoid technology through bioengineering. Nat Mater. 2021;20(2):145–55.
Google Scholar
Lancaster MA, Huch M. Disease modelling in human organoids. DMM. Dis Model Mech. 2019;12(7):dmm039347.
Google Scholar
Andrews MG, Nowakowski TJ. Human brain development through the lens of cerebral organoid models. Brain Res. 2019;1725:146470.
Google Scholar
Walker MJ, Nielsen J, Goddard E, Harris A, Hutchison K. Induced pluripotent stem cell-based Systems for Personalising Epilepsy Treatment: research ethics challenges and new insights for the ethics of personalised medicine. AJOB Neurosci. 2022;13(2):120–31.
Google Scholar
Harris AR, Walker MJ, Gilbert F, McGivern P. Investigating the feasibility and ethical implications of phenotypic screening using stem cell-derived tissue models to detect and manage disease. Stem Cell Reports. 2022;17(5):1023–32.
Google Scholar
Kiatpongsan S, Sipp D. Monitoring and regulating offshore stem cell clinics. Science (80- ). 2009;323(5921):1564–5.
Google Scholar
Lv J, Su Y, Song L, Gong X, Peng Y. Stem cell ‘therapy’ advertisements in China: Infodemic, regulations and recommendations. Cell Prolif. 2020;53(12):e12937.
Google Scholar
U.S. Food and Drug Administration (FDA). Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use. Silver Spring: Guidance for Industry and Food and Drug Administration Staff; 2020. FDA-2017-D-6146-0001.
Chirba M, Noble A. Our bodies, our cells: FDA regulation of autologous adult stem cell therapies: Bill of Health (Boston College Law School Faculty Papers); 2013.
Lysaght T, Campbell AV. Broadening the scope of debates around stem cell research. Bioethics. 2013;27(5):251–6.
Google Scholar
Berkowitz AL, Miller MB, Mir SA, Cagney D, Chavakula V, Guleria I, et al. Glioproliferative lesion of the spinal cord as a complication of “stem-cell tourism”. N Engl J Med. 2016;375(2):196–8.
Google Scholar
Thirabanjasak D, Tantiwongse K, Thorner PS. Angiomyeloproliferative lesions following autologous stem cell therapy. J Am Soc Nephrol. 2010;21(7):1218 LP–1222.
Google Scholar
Ballantyne C. Fetal stem cells cause tumor in a teenage boy. Sci Am. 2009. Available from: https://blogs.scientificamerican.com/news-blog/embryonic-stem-cells-cause-cancer-i-2009-02-19/#:~:text=The%20tumor%20was%20benign%2C%20doctors,of%20Scientific%20American%20and%20elsewhere.
Jabr F. In the flesh: the embedded dangers of untested stem cell cosmetics. Sci Am. 2012. Available from: https://www.scientificamerican.com/article/stem-cell-cosmetics/.
Kuriyan AE, Albini TA, Townsend JH, Rodriguez M, Pandya HK, Leonard RE, et al. Vision loss after Intravitreal injection of autologous “stem cells” for AMD. N Engl J Med. 2017;376(11):1047–53.
Google Scholar
Mehat MS, Sundaram V, Ripamonti C, Robson AG, Smith AJ, Borooah S, et al. Transplantation of human embryonic stem cell-derived retinal pigment epithelial cells in macular degeneration. Ophthalmology. 2018;125(11):1765–75.
Google Scholar
Mandai M, Watanabe A, Kurimoto Y, Hirami Y, Morinaga C, Daimon T, et al. Autologous induced stem-cell–derived retinal cells for macular degeneration. N Engl J Med. 2017;376(11):1038–46.
Google Scholar
Hess DC, Wechsler LR, Clark WM, Savitz SI, Ford GA, Chiu D, et al. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017;16(5):360–8.
Google Scholar
Reardon S. First pig-to-human heart transplant: what can scientists learn? Nature. 2022;601:305–6.
Google Scholar
Gilbert F, Harris AR, Kapsa RMI. Efficacy testing as a primary purpose of phase 1 clinical trials: is it applicable to first-in-human bionics and Optogenetics trials? AJOB Neurosci. 2012;3(2):20–2.
Google Scholar
Gilbert F, Harris AR, Kapsa RMI. Controlling brain cells with light: ethical considerations for Optogenetic clinical trials. AJOB Neurosci. 2014;5(3):3–11.
Google Scholar
Xu L, Wang J, Liu Y, Xie L, Su B, Mou D, et al. CRISPR-edited stem cells in a patient with HIV and acute lymphocytic leukemia. N Engl J Med. 2019;381(13):1240–7.
Google Scholar
Lysaght T, Lipworth W, Hendl T, Kerridge I, Lee T-L, Munsie M, et al. The deadly business of an unregulated global stem cell industry. J Med Ethics. 2017;43(11):744 LP–746.
Google Scholar
Turner L. The US direct-to-consumer marketplace for autologous stem cell interventions. Perspect Biol Med. 2018;61(1):7–24.
Google Scholar
Sipp D. Challenges in the regulation of autologous stem cell interventions in the United States. Perspect Biol Med. 2018;61(1):25–41.
Google Scholar
www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinical-translation. ISSCR guidelines for stem cell science and clinical translation. 2021.
Uhlhaas PJ, Singer W. Neural synchrony in brain disorders: relevance for cognitive dysfunctions and pathophysiology. Neuron. 2006;52(1):155–68.
Google Scholar
Paşca AM, Sloan SA, Clarke LE, Tian Y, Makinson CD, Huber N, et al. Functional cortical neurons and astrocytes from human pluripotent stem cells in 3D culture. Nat Methods. 2015;12(7):671–8.
Google Scholar
Tomaskovic-Crook E, Zhang P, Ahtiainen A, Kaisvuo H, Lee CY, Beirne S, et al. Human neural tissues from neural stem cells using conductive biogel and printed polymer microelectrode arrays for 3D electrical stimulation. Adv Healthc Mater. 2019;8(15):1900425.
Google Scholar
U.S. Food and Drug Administration (FDA). Preclinical assessment of investigational cellular and gene therapy products. Silver Spring; 2013. FDA-2012-D-1038.
U.S. Food and Drug Administration (FDA). Considerations for the design of early-phase clinical trials of cellular and gene therapy products. Silver Spring; 2015. FDA-2013-D-0576.
Hyun I, Taylor P, Testa G, Dickens B, Jung KW, McNab A, et al. Ethical standards for human-to-animal chimera experiments in stem cell research. Cell Stem Cell. 2007;1(2):159–63.
Google Scholar
Harris A. Comment to human-specific gene ARHGAP11B promotes basal progenitor amplification and neocortex expansion. Science. 2015;347:1465–70.
Google Scholar
Chen HI, Wolf JA, Blue R, Song MM, Moreno JD, Ming G, et al. Transplantation of human brain Organoids: revisiting the science and ethics of brain chimeras. Cell Stem Cell. 2019;25(4):462–72.
Google Scholar
Harris AR, McGivern P, Ooi L. Modeling emergent properties in the brain using tissue models to investigate neurodegenerative disease. Neuroscientist. 2020;26(3):224–30.
Google Scholar
Koplin JJ, Savulescu J. Moral limits of brain Organoid research. J Law, Med Ethics. 2019;47(4):760–7.
Google Scholar
Ohayon EL, Tsang PW, Lam A. A computational window into the problem with organoids: approaching minimal substrates for consciousness. Washington, D.C.: Society for Neuroscience; 2019.
Kagan BJ, Duc D, Stevens I, Gilbert F. Neurons embodied in a virtual world: evidence for Organoid ethics? AJOB Neurosci. 2022;13(2):114–7.
Google Scholar
Shepherd J. Consciousness and moral status. Consciousness and moral status: Taylor & Francis; 2018.
Google Scholar
Jaworska A, Tannenbaum J. The Grounds of Moral Status [Internet]. Available from: http://plato.stanford.edu/entries/grounds-moral-status/
Lavazza A, Massimini M. Cerebral organoids: ethical issues and consciousness assessment. J Med Ethics. 2018;44(9):606 LP–610.
Google Scholar
Lavazza A. Potential ethical problems with human cerebral organoids: consciousness and moral status of future brains in a dish. Brain Res. 2021;1750:147146.
Google Scholar
Hansson SO. Implant ethics. J Med Ethics. 2005;31(9):519 LP–525.
Google Scholar
Gilbert F. Self-Estrangement & Deep Brain Stimulation: ethical issues related to forced Explantation. Neuroethics. 2015;8(2):107–14.
Google Scholar
Gilbert F, Viaña JNM, Ineichen C. Deflating the “DBS causes personality changes” bubble. Neuroethics. 2021;14(1):1–17.
Google Scholar
Gilbert F, Viaña JN. A personal narrative on living and dealing with psychiatric symptoms after DBS surgery. Narrat Inq Bioeth. 2018;8(1):67–77.
Google Scholar
Klaming L, Haselager P. Did my brain implant make me do it? Questions raised by DBS regarding psychological continuity, responsibility for action and mental competence. Neuroethics. 2013;6(3):527–39.
Google Scholar
Chadwick RF. The market for bodily parts: Kant and duties to oneself. J Appl Philos. 1989;6(2):129–40.
Google Scholar
Svenaeus F. The body as gift, resource or commodity? Heidegger and the ethics of organ transplantation. J Bioeth Inq. 2010;7(2):163–72.
Google Scholar
Gold E. Body parts: property rights and the ownership of human biological materials. Washington, D.C.: Georgetown University Press; 1997.
Fiduciary Duty of Researchers – the Spleen Case – Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990) [Internet]. 1998. Available from: https://biotech.law.lsu.edu/cases/consent/Moore_v_Regents.htm
Allen MJ, Powers MLE, Gronowski KS, Gronowski AM. Human tissue ownership and use in research: what Laboratorians and researchers should know. Clin Chem. 2010;56(11):1675–82.
Google Scholar
Wall J. Being and owning: the body, bodily material, and the law. Oxford: Oxford University Press; 2015. p. 235.
Google Scholar
Dickenson D. Property in the body: feminist perspectives. In: Cambridge bioethics and law. 2nd ed. Cambridge: Cambridge University Press; 2017.
Www.isscr.org/docs/default-source/policy-documents/isscr-informed-consent-standards-for-stem-cell-based-interventions.pdf. Informed Consent Standard for Stem Cell-Based Interventions Offered Outside of Formal Clinical Trials. 2019;
Greely HT. Human brain surrogates research: the onrushing ethical dilemma. Am J Bioeth. 2021;21(1):34–45.
Google Scholar
Marks PW, Witten CM, Califf RM. Clarifying stem-cell Therapy’s benefits and risks. N Engl J Med. 2016;376(11):1007–9.
Google Scholar
Gilbert F, Viaña JNM, O’Connell CD, Dodds S. Enthusiastic portrayal of 3D bioprinting in the media: ethical side effects. Bioethics. 2018;32(2):94–102.
Google Scholar
Gilbert F, O’Connell CD, Mladenovska T, Dodds S. Print me an organ? Ethical and regulatory issues emerging from 3D bioprinting in medicine. Sci Eng Ethics. 2018;24(1):73–91.
Google Scholar
Harris AR, Gilbert F. Military medicine research: incorporation of high risk of irreversible harms into a stratified risk framework for clinical trials. In: Health Care in Contexts of risk, uncertainty, and hybridity military and humanitarian health ethics: Springer; 2022. p. 253–73.
Baer AR, Devine S, Beardmore CD, Catalano R. Clinical investigator responsibilities. J Oncol Pract. 2011;7(2):124–8.
Google Scholar
Feehan AK, Garcia-Diaz J. Investigator responsibilities in clinical research. Ochsner J. 2020;20(1):44–9.
Google Scholar
Dubinsky PM, Henry KA. The fundamentals of clinical research: a universal guide for implementing good clinical practice: Wiley; 2022. p. 2–5.
Google Scholar
