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A review of osteoinductive testing methods and sterilization processes for demineralized bone

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Abstract

Allogeneic demineralized bone has been used extensively as a clinical graft material because it has osteoinductive and osteoconductive properties. Concerns over processing and terminal sterilization procedures that may reduce performance have led clinicians to call for assurances of product potency. There is extensive experience on effects of demineralized bone in animal and cell culture models with the possibility for future evidence-based standards for release of products. Evaluation of the current state of knowledge leads to the fact that we cannot conclude that performance of different lots of demineralized bone allografts in in vivo or in vitro test systems can be used as a measure of clinical performance. It may be possible to adopt an osteoinductivity standard for release-to-market, but it should be followed by clinical monitoring and further research.

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Abbreviations

BMP:

Bone morphogenetic protein

3D:

Three-dimensional

DBP:

Demineralized bone powder

ELISA:

Enzyme-linked immunosorbent assay

EtO:

Ethylene oxide

hDF:

Human dermal fibroblasts

rhBMP-2:

Recombinant human BMP-2

SAOS:

A line of human osteosarcoma cells

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Authors and Affiliations

  1. Department of Orthopedic Surgery, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02115, USA

    Julie Glowacki

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  1. Julie Glowacki
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Presented in part at the 27th Annual Meeting of the American Association of Tissue Banks, San Diego, CA, August 24, 2003.

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Glowacki, J. A review of osteoinductive testing methods and sterilization processes for demineralized bone. Cell Tissue Banking 6, 3–12 (2005). https://doi.org/10.1007/s10561-005-4252-z

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  • DOI: https://doi.org/10.1007/s10561-005-4252-z

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