<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Deshpande, Rucha</style></author><author><style face="normal" font="default" size="100%">Shukla, Swati</style></author><author><style face="normal" font="default" size="100%">Kale, Amod</style></author><author><style face="normal" font="default" size="100%">Deshmukh, Narendra</style></author><author><style face="normal" font="default" size="100%">Nisal, Anuya</style></author><author><style face="normal" font="default" size="100%">Venugopalan, Premnath</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Silk fibroin microparticle scaffold for use in bone void filling: safety and efficacy studies</style></title><secondary-title><style face="normal" font="default" size="100%">ACS Biomaterials Science &amp; Engineering</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Biocompatibility</style></keyword><keyword><style  face="normal" font="default" size="100%">biological safety</style></keyword><keyword><style  face="normal" font="default" size="100%">bone void filler</style></keyword><keyword><style  face="normal" font="default" size="100%">ISO 10993</style></keyword><keyword><style  face="normal" font="default" size="100%">M-RSF</style></keyword><keyword><style  face="normal" font="default" size="100%">Serioss</style></keyword><keyword><style  face="normal" font="default" size="100%">Silk fibroin</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2022</style></year><pub-dates><date><style  face="normal" font="default" size="100%">MAR</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">8</style></volume><pages><style face="normal" font="default" size="100%">1226-1238</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;
	Silk fibroin (SF) is a natural biocompatible protein polymer extracted from cocoons of silkworm Bombyx mori. SF can be processed into a variety of different forms and shapes that can be used as scaffolds to support bone regeneration. Threedimensional (3D) SF scaffolds have shown promise in bone-void -filling applications. In in vitro studies, it has been demonstrated that a microparticle-based SF (M-RSF) scaffold promotes the differentiation of stem cells into an osteoblastic lineage. The expression of differentiation markers was also significantly higher for M-RSF scaffolds as compared to other SF scaffolds and commercial ceramic scaffolds. In this work, we have evaluated the in vitro and in vivo biocompatibility of M-RSF scaffolds as per the ISO 10993 guidelines in a Good Laboratory Practice (GLP)-certified facility. The cytotoxicity, immunogenicity, genotoxicity, systemic toxicity, and implantation studies confirmed that the M-RSF scaffold is biocompatible. Further, the performance of the MRSF scaffold to support bone formation was evaluated in in vivo bone implantation studies in a rabbit model. Calcium sulfate (CaSO4) scaffolds were chosen as reference material for this study as they are one of the preferred materials for bone-void -filling applications. M-RSF scaffold implantation sites showed a higher number of osteoblast and osteoclast cells as compared to CaSO4 implantation sites indicating active bone remodeling. The number density of osteocytes was double for M-RSF scaffold implantation sites, and these M-RSF scaffold implantation sites were characterized by enhanced collagen deposition, pointing toward a finer quality of the new bone formed. Moreover, the M-RSF scaffold implantation sites had a negligible incidence of secondary fractures as compared to the CaSO4 implantation sites (similar to 50% sites with secondary fracture), implying a reduction in postsurgical complications. Thus, the study demonstrates that the M-RSF scaffold is nontoxic for bone-void -filling applications and facilitates superior healing of fracture defects as compared to commercial calcium-based bone void fillers.&lt;/p&gt;
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	Foreign&lt;/p&gt;
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	5.395&lt;/p&gt;
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