» Articles » PMID: 28185142

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

Overview
Journal Sci Eng Ethics
Date 2017 Feb 11
PMID 28185142
Citations 50
Authors
Affiliations
Soon will be listed here.
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.

Citing Articles

3D bioprinting for the construction of drug testing models-development strategies and regulatory concerns.

Mallya D, Gadre M, Varadharajan S, Vasanthan K Front Bioeng Biotechnol. 2025; 13:1457872.

PMID: 40028291 PMC: 11868281. DOI: 10.3389/fbioe.2025.1457872.


Extrusion bioprinting: meeting the promise of human tissue biofabrication?.

Holland I Prog Biomed Eng (Bristol). 2025; 7(2).

PMID: 39904058 PMC: 11894458. DOI: 10.1088/2516-1091/adb254.


Three-Dimensional Printing/Bioprinting and Cellular Therapies for Regenerative Medicine: Current Advances.

Sousa A, Alvites R, Lopes B, Sousa P, Moreira A, Coelho A J Funct Biomater. 2025; 16(1).

PMID: 39852584 PMC: 11765675. DOI: 10.3390/jfb16010028.


Bioprinting and Intellectual Property: Challenges, Opportunities, and the Road Ahead.

Kantaros A, Ganetsos T, Petrescu F, Alysandratou E Bioengineering (Basel). 2025; 12(1).

PMID: 39851350 PMC: 11761581. DOI: 10.3390/bioengineering12010076.


[3D printing in surgery: relevance of technology maturity assessment in bioprinting research studies].

Laubach M, Hartmann H, Holzapfel B, Mayer-Wagner S, Schenke-Layland K, Hutmacher D Chirurgie (Heidelb). 2024; .

PMID: 39630288 DOI: 10.1007/s00104-024-02197-5.


References
1.
Marchioli G, van Gurp L, van Krieken P, Stamatialis D, Engelse M, van Blitterswijk C . Fabrication of three-dimensional bioplotted hydrogel scaffolds for islets of Langerhans transplantation. Biofabrication. 2015; 7(2):025009. DOI: 10.1088/1758-5090/7/2/025009. View

2.
Hyun I . The bioethics of stem cell research and therapy. J Clin Invest. 2010; 120(1):71-5. PMC: 2798696. DOI: 10.1172/JCI40435. View

3.
Gilbert F . The burden of normality: from 'chronically ill' to 'symptom free'. New ethical challenges for deep brain stimulation postoperative treatment. J Med Ethics. 2012; 38(7):408-12. DOI: 10.1136/medethics-2011-100044. View

4.
Gilbert F . A Threat to Autonomy? The Intrusion of Predictive Brain Implants. AJOB Neurosci. 2016; 6(4):4-11. PMC: 4685604. DOI: 10.1080/21507740.2015.1076087. View

5.
Murphy S, Atala A . 3D bioprinting of tissues and organs. Nat Biotechnol. 2014; 32(8):773-85. DOI: 10.1038/nbt.2958. View