Ethics of Early Clinical Trials of Bio-Artificial Organs
– The article is a summary of the international meeting “Ethics of Early Clinical Trials of Bio-Artificial Organs” held in February
July 2022. Organ Transplantation, the official scientific journal of the European Society for Organ Transplantation, publishes in its latest issue a meeting report of the international workshop held online in February under the title “Ethics of Early Clinical Trials of Bio-Artificial Organs.”
In the context of the Horizon 2020-funded, the VANGUARD project organized this meeting to develop a bioartificial pancreas for treating patients with type 1 diabetes. Furthermore, this project aligns with the BRAVꓱ project, which aims to develop a regenerative treatment for ischemic heart disease (IHD): an innovative biological ventricular assist device (BioVAD).
The article reports the main conclusions of the meeting that brought together ethicists, researchers, and clinicians from all over the world to discuss the ethics of early phase clinical trials in regenerative medicine in transplantation.
In addition to the conferences on the theory of ethically responsible-clinical translation, the workshop presented three cases of innovative research projects in Bioartificial Organ Technologies. The BRAVꓱ project was one of them. Thus, Olalla Iglesias and Manuel Mazo, researchers in Regenerative Medicine and Cell Therapy at Cima and Clinica Universidad de Navarra, presented the remains and progress of the BRAVꓱ project.
BRAVꓱ: lifelong functional support for ischemic heart disease
The BRAVꓱ project is an international research initiative for cardiac regeneration. Clíica Universidad de Navarra (Spain) coordinates the project in which 13 other European institutions from 5 countries participate.
The project combines regenerative medicine and 3D bioprinting with computational modeling to develop a biological ventricular assist device called BioVAD. It aims to provide lifelong assistance to patients with ischemic heart disease. The researchers aim to get the device “as close to the patient’s bedside as possible in the shortest possible time.” The device consists of a 3D-printed microfiber scaffold with human-induced pluripotent stem cells, which integrates into the patient’s heart and restores cardiac function. In addition, computational modeling is used to assess cardiac geometry and tissue mechanics so that the design of the assistive device can be tailored to each patient’s heart.