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1 Introduction
Pages 1-6

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From page 1...
... Reconstitution of gametogenesis has many potential uses and applications, including basic research into mammalian developmental biology and use in animal breeding. Were the in vitro reconstitution of human gametogenesis ever achieved and in vitro–derived gametes ever approved for human use, it could also serve as an assisted reproductive technology (ART)
From page 2...
... ART = assisted reproductive technology; iPSCs = induced pluripotent stem cells; PGCLCs = primordial germ cell–like cells. SOURCES: Presented by Paula Amato, April 19, 2023; Saitou and Hayashi, 2021.
From page 3...
... Were this technology to ever develop fully and become available for clinical practice, any use of in vitro–derived human gametes would raise important scientific, ethical, social, and regulatory questions that may not be answered by scientific, bioethics, and regulatory communities alone -- they will likely require broader societal engagement. In anticipation that research development may continue, a workshop was convened to review the state of the science, understand what is driving progress, what is likely to be achievable versus unrealistic, and recognize the urgent issues that in vitro–derived gametes could raise.
From page 4...
... Because of this "unfinished agenda" for developing in vitro–derived human gametes and the multiple social, ethical, and legal concerns, he said, it is timely and important to discuss the landscape of IVG research, scientific and technical barriers, legal and regulatory frameworks relevant to conducting and overseeing research, potential clinical impacts, and social and ethical concerns and considerations. ORGANIZATION OF THE WORKSHOP A planning committee of the National Academies of Sciences, Engineering, and Medicine (the National Academies)
From page 5...
... Chapter 6 provides an overview of discussions that imagined what a potential clinical research pathway for human IVG would entail were it permitted and pursued. Speakers and participants shared perspectives on relevant legal and regulatory frameworks and what types of preclinical research and validation would be needed before considering any initial clinical trial.


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