Translation of a spinal bone cement product from bench to bedside

Spinal acrylic bone cements (ABCs) are used clinically for percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) to treat osteoporotic vertebral compression fractures. Product translation of spinal ABC products followed the design control processes including design verification and validation. The...

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Autores principales:	Fei Feng, Mengmeng Chen, Xuan Wang, Hongwei Zhang, Hongtao Nie, Hai Tang
Formato:	article
Lenguaje:	EN
Publicado:	KeAi Communications Co., Ltd. 2022
Materias:	Bone cement Spine Translational research Vertebroplasty Kyphoplasty Safety and efficacy Materials of engineering and construction. Mechanics of materials TA401-492 Biology (General) QH301-705.5
Acceso en línea:	https://doaj.org/article/b6864fca4c984bcd85e6a23a16e39396
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spelling	oai:doaj.org-article:b6864fca4c984bcd85e6a23a16e393962021-11-28T04:35:06ZTranslation of a spinal bone cement product from bench to bedside2452-199X10.1016/j.bioactmat.2021.08.011https://doaj.org/article/b6864fca4c984bcd85e6a23a16e393962022-04-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2452199X21003881https://doaj.org/toc/2452-199XSpinal acrylic bone cements (ABCs) are used clinically for percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) to treat osteoporotic vertebral compression fractures. Product translation of spinal ABC products followed the design control processes including design verification and validation. The bench to bedside translation of the first Chinese spinal ABC product (Alliment®, namely Alliment Cement) approved by National Medical Products Administration of China was investigated and another commercial product served as the control (Osteopal®V, namely Osteopal V Cement). Results of non-clinical bench performance verification tests of compression, bending and monomer release showed that the newly marketed Alliment Cement is similar to the Osteopal V Cement with properties of both meeting the criteria specified by standards. The Alliment Cement demonstrated good biocompatibility during the 26 weeks’ bone implantation test. Porcine cadaver validation tests further revealed that the Alliment Cement satisfied the needs for both PVP and PKP procedures. A post-approval, retrospective clinical investigation further demonstrated the safety and efficacy of the Alliment Cement, with a significant reduction of pain and the improved stability of the fractured vertebral bodies. A successful translation of biomaterial medical products needs close collaborations among academia, industry, healthcare professionals and regulatory agencies.Fei FengMengmeng ChenXuan WangHongwei ZhangHongtao NieHai TangKeAi Communications Co., Ltd.articleBone cementSpineTranslational researchVertebroplastyKyphoplastySafety and efficacyMaterials of engineering and construction. Mechanics of materialsTA401-492Biology (General)QH301-705.5ENBioactive Materials, Vol 10, Iss , Pp 345-354 (2022)
institution	DOAJ
collection	DOAJ
language	EN
topic	Bone cement Spine Translational research Vertebroplasty Kyphoplasty Safety and efficacy Materials of engineering and construction. Mechanics of materials TA401-492 Biology (General) QH301-705.5
spellingShingle	Bone cement Spine Translational research Vertebroplasty Kyphoplasty Safety and efficacy Materials of engineering and construction. Mechanics of materials TA401-492 Biology (General) QH301-705.5 Fei Feng Mengmeng Chen Xuan Wang Hongwei Zhang Hongtao Nie Hai Tang Translation of a spinal bone cement product from bench to bedside
description	Spinal acrylic bone cements (ABCs) are used clinically for percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) to treat osteoporotic vertebral compression fractures. Product translation of spinal ABC products followed the design control processes including design verification and validation. The bench to bedside translation of the first Chinese spinal ABC product (Alliment®, namely Alliment Cement) approved by National Medical Products Administration of China was investigated and another commercial product served as the control (Osteopal®V, namely Osteopal V Cement). Results of non-clinical bench performance verification tests of compression, bending and monomer release showed that the newly marketed Alliment Cement is similar to the Osteopal V Cement with properties of both meeting the criteria specified by standards. The Alliment Cement demonstrated good biocompatibility during the 26 weeks’ bone implantation test. Porcine cadaver validation tests further revealed that the Alliment Cement satisfied the needs for both PVP and PKP procedures. A post-approval, retrospective clinical investigation further demonstrated the safety and efficacy of the Alliment Cement, with a significant reduction of pain and the improved stability of the fractured vertebral bodies. A successful translation of biomaterial medical products needs close collaborations among academia, industry, healthcare professionals and regulatory agencies.
format	article
author	Fei Feng Mengmeng Chen Xuan Wang Hongwei Zhang Hongtao Nie Hai Tang
author_facet	Fei Feng Mengmeng Chen Xuan Wang Hongwei Zhang Hongtao Nie Hai Tang
author_sort	Fei Feng
title	Translation of a spinal bone cement product from bench to bedside
title_short	Translation of a spinal bone cement product from bench to bedside
title_full	Translation of a spinal bone cement product from bench to bedside
title_fullStr	Translation of a spinal bone cement product from bench to bedside
title_full_unstemmed	Translation of a spinal bone cement product from bench to bedside
title_sort	translation of a spinal bone cement product from bench to bedside
publisher	KeAi Communications Co., Ltd.
publishDate	2022
url	https://doaj.org/article/b6864fca4c984bcd85e6a23a16e39396
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Translation of a spinal bone cement product from bench to bedside

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