Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine

Abstract

Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

Consent in body donation

“…A donor could register at 18 years of age and die aged 108 and body parts from that donor could then be stored, displayed, and used for 100 years or more after their death, i.e., approximately two centuries after that person gave consent. Even if they were told about all the things that could possibly follow donation that were known about at the time of registration, societal and technological developments will inevitably have occurred in the period following this that enable things to be done with and to their donated bodies that they simply could not have been fully informed about with any specificity at the time that their consent was obtained (Jones, 2007;Cornwall, 2016;Cornwall et al, 2016;Márquez-Grant & Errickson, 2017;Champney et al, 2018;Gilbert et al, 2018).…”

Recent Applications of Three Dimensional Printing in Cardiovascular Medicine

“…Regarding 3D bioprinted products, their classification mainly depends on whether these devices are mass-produced or custom-made. In current practice, custom-made devices, which are manufactured in accordance with a specific prescription for a specific individual, are exempt from normal quality system requirements or conformity assessment requirements by most regulatory bodies in both in the USA and in the EU [143,144].…”

Three-dimensional neuronal cell culture: in pursuit of novel treatments for neurodegenerative disease

“…[86][87][88] These involve questions related to the novelty of the technology itself, but also regarding its integration with biologic products (e.g. stem cell technology).…”

“…Several topics of debate are the choice and use of animals, use of cells sourced from embryonic and fetal tissues, and the privacy-related concerns associated with biobanking. [87,88] Other factors worth to consider include data integrity and appropriate study design, which could prevent premature transition from the bench to the bedside stage. [86] This bedside stage, which involves clinical trials, predominantly addresses questions related to the participants; selection of participants, and most importantly, the risks for the participant, which should be appropriate compared with the potential benefits on the larger scale.…”