Clinical Translation of Bio-Artificial Pancreas Therapies: Ethical, Legal and Psychosocial Interdisciplinary Considerations and Key Recommendations.

Autor:	de Jongh D; Department of Nephrology and Transplantation, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Netherlands.; Department of Medical Ethics, Philosophy and History of Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Netherlands., Thom RL; Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.; King's College, London, United Kingdom., Cronin AJ; Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.; King's College, London, United Kingdom., Bunnik EM; Department of Medical Ethics, Philosophy and History of Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Netherlands., Massey EK; Department of Nephrology and Transplantation, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Netherlands.
Jazyk:	angličtina
Zdroj:	Transplant international : official journal of the European Society for Organ Transplantation [Transpl Int] 2023 Sep 18; Vol. 36, pp. 11705. Date of Electronic Publication: 2023 Sep 18 (Print Publication: 2023).
DOI:	10.3389/ti.2023.11705
Abstrakt:	The field of regenerative medicine offers potential therapies for Type 1 Diabetes, whereby metabolically active cellular components are combined with synthetic medical devices. These therapies are sometimes referred to as "bioartificial pancreases." For these emerging and rapidly developing therapies to be clinically translated to patients, researchers must overcome not just scientific hurdles, but also navigate complex legal, ethical and psychosocial issues. In this article, we first provide an introductory overview of the key legal, ethical and psychosocial considerations identified in the existing literature and identify areas where research is currently lacking. We then highlight two principal areas of concern in which these discrete disciplines significantly overlap: 1) individual autonomy and 2) access and equality. Using the example of beta-cell provenance, we demonstrate how, by harnessing an interdisciplinary approach we can address these key areas of concern. Moreover, we provide practical recommendations to researchers, clinicians, and policymakers which will help to facilitate the clinical translation of this cutting-edge technology for Type 1 Diabetes patients. Finally, we emphasize the importance of exploring patient perspectives to ensure their responsible and acceptable translation from bench to body. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 de Jongh, Thom, Cronin, Bunnik and Massey.)
Databáze:	MEDLINE
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