
Abstract Stem cell-derived (SCD)-gametes derived from induced or autologous (i.e. patient-specific) cells may help mitigate human fertility problems caused by physiological or social factors in the (near) future. While this technology is still in its infancy, recent advancements with SCD-gametes generated from mouse pluripotent stem cells have led some researchers to expect—and investors to anticipate—the clinical introduction of human gametes derived from induced pluripotent stem cells (iPSCD-gametes) within two decades. However, it remains to be investigated how realistic these expectations are, and how they would balance against careful consideration of technical, ethical, legal, and societal aspects, including—but not limited to—safety and effectiveness. This mini-review aims to encourage that investigation by providing a brief overview of the state-of-the-art and highlighting the breadth of issues involved in the potential clinical introduction of human iPSCD-gametes. These issues emerge before (Stage 1), during (Stage 2), and after (Stage 3) clinical trials, and are discussed in that order. Issues discussed in the context of Stage 1 suggest that gathering the evidence required to preclinically assess the safety of human iPSCD-gametes will be time-consuming and require parallel experiments with sensitive research materials. Issues discussed in the context of Stage 2 suggest that it might take several years for human iPSCD-gametes to transition through distinct clinical trial phases, and that inevitable (and unforeseeable) variations in the quality of human iPSCD-gametes are likely to further slow this down. Finally, issues discussed in the context of Stage 3 suggest that offering human iPSCD-gametes clinically will require addressing questions of accountability and monitoring, some of which might be difficult to formalize by law. Combined, these findings suggest that a responsible clinical introduction of human iPSCD-gametes may take considerably longer than expected, underscoring the importance of transdisciplinary collaborations with a broad range of stakeholders to make well-informed and well-considered choices about their development and application.
Philosophy and Religion, assisted reproductive technologies, DISCLOSURE, induced pluripotent stem cells, INDUCTION, IN-VITRO GAMETOGENESIS, Biology and Life Sciences, FETAL TISSUE, stem cell-derived gametes, Mini-Review, in vitro gametogenesis, ethics, ESHRE TASK-FORCE, clinical application, society, RECONSTITUTION, PERSPECTIVES, Medicine and Health Sciences, DONATION, human, law, FOLLOW-UP, ETHICS
Philosophy and Religion, assisted reproductive technologies, DISCLOSURE, induced pluripotent stem cells, INDUCTION, IN-VITRO GAMETOGENESIS, Biology and Life Sciences, FETAL TISSUE, stem cell-derived gametes, Mini-Review, in vitro gametogenesis, ethics, ESHRE TASK-FORCE, clinical application, society, RECONSTITUTION, PERSPECTIVES, Medicine and Health Sciences, DONATION, human, law, FOLLOW-UP, ETHICS
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