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.
Transpl Int. 2023 Sep 18;36:11705. doi: 10.3389/ti.2023.11705. eCollection 2023.
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.
再生医学领域为 1 型糖尿病提供了潜在的治疗方法，即将代谢活跃的细胞成分与合成医疗设备相结合。这些治疗方法有时被称为“生物人工胰腺”。为了将这些新兴的、快速发展的治疗方法转化为临床应用于患者，研究人员不仅必须克服科学障碍，还必须应对复杂的法律、伦理和社会心理问题。在本文中，我们首先提供现有文献中确定的关键法律、伦理和社会心理问题的介绍性概述，并确定当前研究中缺乏的领域。然后，我们强调两个主要关注领域，这两个领域在离散学科上有显著的重叠：1）个体自主性和 2）获取和公平性。我们以β细胞起源为例，展示了如何通过利用跨学科方法来解决这些关键问题。此外，我们为研究人员、临床医生和政策制定者提供了实用的建议，这将有助于促进该技术在 1 型糖尿病患者中的临床转化。最后，我们强调探索患者观点的重要性，以确保从实验室到身体的负责任和可接受的转化。
