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Ethics of Early Clinical Trials of Bio-Artificial Organs

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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… Click to show full 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.

Keywords: bio artificial; clinical trials; artificial organs; medicine; research; ethics early

Journal Title: Transplant International
Year Published: 2022

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