Design and evaluation of 3D-printed Sr-HT-Gahnite bioceramic for FDA regulatory submission: A Good Laboratory Practice sheep study.

Newsom, ET; Sadeghpour, A; Entezari, A; Vinzons, JLU; Stanford, RE; Mirkhalaf, M; Chon, D; Dunstan, CR; Zreiqat, H

Design and evaluation of 3D-printed Sr-HT-Gahnite bioceramic for FDA regulatory submission: A Good Laboratory Practice sheep study.

Newsom, ET Sadeghpour, A Entezari, A

Vinzons, JLU Stanford, RE Mirkhalaf, M Chon, D Dunstan, CR Zreiqat, H

Permalink

Publisher:: Elsevier BV
Publication Type:: Journal Article
Citation:: Acta Biomater, 2023, 156, pp. 214-221
Issue Date:: 2023-01-15

Closed Access

	Filename	Description	Size
	Design and evaluation of 3D-printed Sr-HT-Gahnite bioceramic for FDA regulatory submission - A Good Laboratory Practice sheep study.pdf		1.55 MB	Adobe PDF	View/Open

Copyright Clearance Process

Recently Added
In Progress
Closed Access

This item is closed access and not available.

Full metadata record

Field	Value	Language
dc.contributor.author	Newsom, ET
dc.contributor.author	Sadeghpour, A
dc.contributor.author	Entezari, A https://orcid.org/0000-0003-0504-8364
dc.contributor.author	Vinzons, JLU
dc.contributor.author	Stanford, RE
dc.contributor.author	Mirkhalaf, M
dc.contributor.author	Chon, D
dc.contributor.author	Dunstan, CR
dc.contributor.author	Zreiqat, H
dc.date.accessioned	2023-03-13T01:07:18Z
dc.date.available	2022-01-14
dc.date.available	2023-03-13T01:07:18Z
dc.date.issued	2023-01-15
dc.identifier.citation	Acta Biomater, 2023, 156, pp. 214-221
dc.identifier.issn	1742-7061
dc.identifier.issn	1878-7568
dc.identifier.uri	http://hdl.handle.net/10453/167120
dc.description.abstract	There is an unmet clinical need for a spinal fusion implant material that recapitulates the biological and mechanical performance of natural bone. We have developed a bioceramic, Sr-HT-Gahnite, which has been identified as a potential fusion device material. This material has the capacity to transform the future of the global interbody devices market, with follow on social, economic, and environmental benefits, rooted in its remarkable combination of mechanical properties and bioactivity. In this study, and in line with FDA requirements, the in vivo preclinical systemic biological safety of a Sr-HT-Gahnite interbody fusion device is assessed over 26 weeks in sheep under good laboratory practice (GLP). Following the in-life phase, animals are assessed for systemic biological effects via blood haematology and clinical biochemistry, strontium dosage analysis in the blood and wool, and histopathology examination of the distant organs including adrenals, brain, heart, kidneys, liver, lungs and bronchi, skeletal muscle, spinal nerves close to the implanted sites, ovaries, and draining lymph nodes. Our results show that no major changes in blood haematology or biochemistry parameters are observed, no systemic distribution of strontium to the blood and wool, and no macroscopic or histopathological abnormalities in the distant organs when Sr-HT-Gahnite was implanted, compared to baseline and control values. Together, these results indicate the systemic safety of the Sr-HT-Gahnite interbody fusion device. The results of this study extend to the systemic safety of other Sr-HT-Gahnite implanted medical devices in contact with bone or tissue, of similar size and manufactured using the described processes. STATEMENT OF SIGNIFICANCE: This paper is considered original and innovative as it is the first that thoroughly reports the systemic biological safety of previously undescribed bioceramic material, Sr-HT-Gahnite. The study has been performed under good laboratory practice, in line with FDA requirements for assessment of a new interbody fusion device, making the results broadly applicable to the translation of sheep models to the human cervical spine; and also the translation of Sr-HT-Gahnite as a biomaterial for use in additional applications. We expect this study to be of broad interest to the readership of Acta Biomaterilia. Its findings are directly applicable to researchers and clinicians working in bone repair and the development of synthetic biomaterials.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	Elsevier BV
dc.relation.ispartof	Acta Biomater
dc.relation.isbasedon	10.1016/j.actbio.2022.01.035
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject.classification	Biomedical Engineering
dc.subject.mesh	Humans
dc.subject.mesh	Animals
dc.subject.mesh	Sheep
dc.subject.mesh	Biocompatible Materials
dc.subject.mesh	Prostheses and Implants
dc.subject.mesh	Bone and Bones
dc.subject.mesh	Strontium
dc.subject.mesh	Printing, Three-Dimensional
dc.subject.mesh	Spinal Fusion
dc.subject.mesh	Bone and Bones
dc.subject.mesh	Animals
dc.subject.mesh	Sheep
dc.subject.mesh	Humans
dc.subject.mesh	Strontium
dc.subject.mesh	Biocompatible Materials
dc.subject.mesh	Spinal Fusion
dc.subject.mesh	Prostheses and Implants
dc.subject.mesh	Printing, Three-Dimensional
dc.title	Design and evaluation of 3D-printed Sr-HT-Gahnite bioceramic for FDA regulatory submission: A Good Laboratory Practice sheep study.
dc.type	Journal Article
utslib.citation.volume	156
utslib.location.activity	England
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Engineering and Information Technology
pubs.organisational-group	/University of Technology Sydney/Faculty of Engineering and Information Technology/School of Biomedical Engineering
utslib.copyright.status	closed_access	*
dc.date.updated	2023-03-13T01:07:16Z
pubs.publication-status	Published
pubs.volume	156

Abstract:

There is an unmet clinical need for a spinal fusion implant material that recapitulates the biological and mechanical performance of natural bone. We have developed a bioceramic, Sr-HT-Gahnite, which has been identified as a potential fusion device material. This material has the capacity to transform the future of the global interbody devices market, with follow on social, economic, and environmental benefits, rooted in its remarkable combination of mechanical properties and bioactivity. In this study, and in line with FDA requirements, the in vivo preclinical systemic biological safety of a Sr-HT-Gahnite interbody fusion device is assessed over 26 weeks in sheep under good laboratory practice (GLP). Following the in-life phase, animals are assessed for systemic biological effects via blood haematology and clinical biochemistry, strontium dosage analysis in the blood and wool, and histopathology examination of the distant organs including adrenals, brain, heart, kidneys, liver, lungs and bronchi, skeletal muscle, spinal nerves close to the implanted sites, ovaries, and draining lymph nodes. Our results show that no major changes in blood haematology or biochemistry parameters are observed, no systemic distribution of strontium to the blood and wool, and no macroscopic or histopathological abnormalities in the distant organs when Sr-HT-Gahnite was implanted, compared to baseline and control values. Together, these results indicate the systemic safety of the Sr-HT-Gahnite interbody fusion device. The results of this study extend to the systemic safety of other Sr-HT-Gahnite implanted medical devices in contact with bone or tissue, of similar size and manufactured using the described processes. STATEMENT OF SIGNIFICANCE: This paper is considered original and innovative as it is the first that thoroughly reports the systemic biological safety of previously undescribed bioceramic material, Sr-HT-Gahnite. The study has been performed under good laboratory practice, in line with FDA requirements for assessment of a new interbody fusion device, making the results broadly applicable to the translation of sheep models to the human cervical spine; and also the translation of Sr-HT-Gahnite as a biomaterial for use in additional applications. We expect this study to be of broad interest to the readership of Acta Biomaterilia. Its findings are directly applicable to researchers and clinicians working in bone repair and the development of synthetic biomaterials.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/167120