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Three-Dimensional Bioprinting: Safety, Ethical, and Regulatory Considerations

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3D Bioprinting in Medicine

Abstract

Three-dimensional (3D) bioprinting of tissues or organs holds great potential for several clinical applications in the future. Similar to all new biotechnologies, 3D bioprinting possesses both benefits and risks. Consequently, several ethical, safety, and regulatory issues have to be addressed. Ethical concerns identified involve the ownership of prototypes, harvesting and type of cells and biomaterials, research as well as commercialization of produced constructs. Safety concerns identified are linked to the biocompatibility of bioinks, ex vivo manipulation of cells, and maintenance of aseptic conditions. Regulations are vague and are under the provisions made for tissue engineering. Three-dimensional bioprinting should be considered beyond a conceptual therapy; it would require ethical oversight and the introduction of a robust regulatory framework.

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Conflict of Interest

No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this chapter.

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Authors and Affiliations

  1. Academic Department of Trauma and Orthopaedics, Leeds Teaching Hospitals, University of Leeds, Leeds, UK

    Ippokratis Pountos & Nazzar Tellisi

  2. Chapel Allerton Hospital, Leeds Teaching Hospitals, Leeds, UK

    Ippokratis Pountos & Nazzar Tellisi

  3. Center for Minimally Invasive Therapeutics (C-MIT), University of California Los Angeles, Los Angeles, CA, USA

    Nureddin Ashammakhi

  4. California NanoSystems Institute (CNSI), University of California Los Angeles, Los Angeles, CA, USA

    Nureddin Ashammakhi

  5. Department of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA

    Nureddin Ashammakhi

  6. Biotechnology Research Center, Libyan Authority for Research, Science and Technology, Tripoli, Libya

    Nureddin Ashammakhi

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  1. Ippokratis Pountos
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  2. Nazzar Tellisi
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  3. Nureddin Ashammakhi
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Correspondence to Ippokratis Pountos .

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  1. Otto H. York Department of Chemical and Materials Engineering, New Jersey Institute of Technology, Newark, NJ, USA

    Murat Guvendiren

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Pountos, I., Tellisi, N., Ashammakhi, N. (2019). Three-Dimensional Bioprinting: Safety, Ethical, and Regulatory Considerations. In: Guvendiren, M. (eds) 3D Bioprinting in Medicine. Springer, Cham. https://doi.org/10.1007/978-3-030-23906-0_7

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