Ethics of Early Clinical Trials of Bio-Artificial Organs

Eline M. Bunnik*, Dide de Jongh, the VANGUARD consortium, Emma Massey

*Corresponding author for this work

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Abstract

Regenerative medicine is the new frontier in the field of organ transplantation. Research groups around the world are using regenerative medicine technologies to develop bio-artificial organs for transplantation into human patients. While most of this research is still at the preclinical stage, bio-artificial organ technologies are gearing up for first-in-human clinical trials in the not-too-distant future. What are the ethical conditions under which early-phase clinical research of bio-artificial organs can be conducted safely and responsibly? What lessons can be learned from prior experiences with early-phase clinical trials in adjacent fields of research? This is a Meeting Report of an online international workshop organised in the context of the Horizon 2020-funded VANGUARD project, which is developing a bio-artificial pancreas for the treatment of patients with type 1 diabetes.

Original languageEnglish
Article number10621
JournalTransplant International
Volume35
DOIs
Publication statusPublished - 6 Jul 2022

Bibliographical note

Funding Information:
On 3rd February 2022 an online meeting was held to bring together ethicists, researchers, and clinicians to discuss the ethics of early-phase clinical trials in regenerative medicine in transplantation. The meeting was organised in the context of the VANGUARD project, a European research project which aims to generate a vascularized and immune-protected bio-artificial pancreas that can be transplanted into non-immunosuppressed type 1 diabetes patients. This project is one of 14 projects funded by the European Commission Horizon 2020 programme “Regenerative medicine: from new insights to new applications”. Representatives of other recipients of grants from this call were invited to attend the meeting. The meeting was announced on the website and in newsletters of the European Society for Organ Transplantation (ESOT), and open to the public. In total, 102 people registered, and 74 people attended the meeting. The meeting commenced with a keynote lecture by Jonathan Kimmelman, Professor of Biomedical Ethics and Social Sciences of Medicine at McGill University in Montreal, Canada, and was followed by three brief presentations on three bio-artificial organ technologies, and a panel discussion.

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

Publisher Copyright:
Copyright © 2022 Bunnik, de Jongh and Massey.

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