Erasmus MC, University Medical Centre Rotterdam, Rotterdam, Netherlands.
Transpl Int. 2022 Jul 6;35:10621. doi: 10.3389/ti.2022.10621. eCollection 2022.
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.
再生医学是器官移植领域的新前沿。世界各地的研究小组正在利用再生医学技术开发生物人工器官，以便移植到人类患者体内。虽然这项研究大多仍处于临床前阶段，但生物人工器官技术正准备在不远的将来进行首次人体临床试验。在什么伦理条件下，可以安全、负责任地进行生物人工器官的早期临床研究？在相邻研究领域的早期临床试验中，可以吸取哪些经验教训？这是在 Horizon 2020 资助的 VANGUARD 项目的背景下组织的一次在线国际研讨会的会议报告，该项目正在开发用于治疗 1 型糖尿病患者的生物人工胰腺。
