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  • SAGE Publications  (2)
  • 1
    Online-Ressource
    Online-Ressource
    SAGE Publications ; 2010
    In:  Journal of Biomaterials Applications Vol. 24, No. 5 ( 2010-01), p. 387-400
    In: Journal of Biomaterials Applications, SAGE Publications, Vol. 24, No. 5 ( 2010-01), p. 387-400
    Kurzfassung: Allograft tissues are used in over one million musculoskeletal procedures per year. Consequently, it is crucial tissue banks use procedures to militate against allograft associated bacterial and viral infections. Recent studies have identified an important pathogen inactivation technology for musculoskeletal allografts that utilizes high-dose gamma irradiation (50 kGy) under controlled conditions. A total dose of 50 kGy assures that the current standard for medical devices for a microbial sterility assurance level of 10 — 6 is met. Furthermore, the pathogen inactivation technology results in a greater than four log inactivation of enveloped and nonenveloped viruses. Efficacious clinical outcome from musculoskeletal allografts exposed to this innovative sterilization procedure will require that there is no performance decrement in the allograft’s biological properties. Therefore, to validate this objective, we executed a study focusing on remodeling and osteoconduction of bone allografts treated with a high dose of gamma irradiation (50 kGy), radioprotectants and well-defined operating parameters of temperature and water content. A rabbit calvarial model was used to test the hypothesis that remodeling and osteoconduction of allogeneic bone treated with the new pathogen inactivation technology would be equivalent to nontreated allogeneic bone. Results indicated treated bone allografts were comparable to nontreated allografts. We conclude, therefore, that based on this outcome and other reports, that high doses of gamma irradiation under optimized conditions designed to reduce free radical damage to tissue will provide safer allografts.
    Materialart: Online-Ressource
    ISSN: 0885-3282 , 1530-8022
    Sprache: Englisch
    Verlag: SAGE Publications
    Publikationsdatum: 2010
    ZDB Id: 2072559-0
    SSG: 12
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 2
    In: Journal of Tissue Engineering, SAGE Publications, Vol. 1, No. 1 ( 2010-01), p. 246215-
    Kurzfassung: Human platelet-derived growth factor-BB (hPDGF-BB) is a basic polypeptide growth factor released from platelets at the injury site. It is a multifunctional molecule that regulates DNA synthesis and cell division and induces biological effects that are implicated in tissue repair, atherosclerosis, inflammatory responses, and neoplastic diseases. This paper is an overview of the toxicology data generated from a broad testing platform to determine bone, soft tissue, and systemic responses following administration of rhPDGF-BB. Moreover, the systemic and local toxicity of recombinant human PDGF-BB (rhPDGF-BB) in combination with either beta-tricalcium phosphate (β-TCP) or collagen combined with β-TCP was studied to determine dermal sensitization, irritation, intramuscular tissue responses, pyrogenicity, genotoxicity, and hemolytic properties. All data strongly suggest that rhPDGF-BB either alone or in combination with β-TCP or collagen with β-TCP is biocompatible and has neither systemic nor local toxicity, supporting its safe use in enhancing wound healing in patients.
    Materialart: Online-Ressource
    ISSN: 2041-7314 , 2041-7314
    Sprache: Englisch
    Verlag: SAGE Publications
    Publikationsdatum: 2010
    ZDB Id: 2573915-3
    Standort Signatur Einschränkungen Verfügbarkeit
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