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

Transpl Int. 2023 Sep 18:36:11705. doi: 10.3389/ti.2023.11705. eCollection 2023.

Abstract

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.

Keywords: informed consent; regenerative medicine; tissue engineering; transplantation; type 1 diabetes.

Publication types

  • Review

MeSH terms

  • Diabetes Mellitus, Type 1* / surgery
  • Humans
  • Pancreas, Artificial*
  • Regenerative Medicine

Grants and funding

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 874700.