03055nas a2200289   4500008004100000022001400041245009800055210006900153260000800222300001400230490000600244520215300250653002102403653002202424653002102446653001402467653001002481653001202491653001702503100002102520700001802541700001502559700002302574700001702597700002602614856012502640       2022                        eng d  a2373-987800aSilk fibroin microparticle scaffold for use in bone void filling: safety and efficacy studies0 aSilk fibroin microparticle scaffold for use in bone void filling  cMAR  a1226-12380 v83 a<p>
	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.</p>
10aBiocompatibility10abiological safety10abone void filler10aISO 1099310aM-RSF10aSerioss10aSilk fibroin1 aDeshpande, Rucha1 aShukla, Swati1 aKale, Amod1 aDeshmukh, Narendra1 aNisal, Anuya1 aVenugopalan, Premnath  uhttps://library.ncl.res.in/content/silk-fibroin-microparticle-scaffold-use-bone-void-filling-safety-and-efficacy-studies