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Published on: November 26, 2015
Ethics of Early Clinical Trials of Bio-Artificial Organs
Eline M Bunnik1, Dide de Jongh1, Emma Massey1
1Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Netherlands.
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.
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