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This study aims to explore the biocompatibility of polyvinyl alcohol (PVA) embolization microspheres through in vitro and in vivo evaluation.
Two sizes of PVA microspheres were used for biocompatibility assessment: colorless microspheres (1 g microsphere and 7 mL 0.9% sodium chloride (SC)/vial, size: 500–700 μm) and blue microspheres (2 g microspheres and 7 mL 0.9% SC/vial, size: 500–700 μm). In vitro cytotoxicity was evaluated in L929 cells using the MTT assay. Acute systemic toxicity and subchronic intravenous toxicity were assessed in 20 ICR mice and 40 SD rats, respectively, using 28 repeated doses. Skin sensitization tests were performed on 30 adult albino guinea pigs using the maximum value test, and intradermal reaction tests were performed on New Zealand white rabbits. The hemolysis rate of PVA microspheres was determined using rabbit blood. Furthermore, genotoxicity was assessed using a bacterial reverse mutation assay and a mouse lymphoma cell mutation assay.
No cytotoxicity, hemolytic, or acute toxicity was found in the PVA microspheres. Slight fluctuations in biochemical parameters were observed in the 28-day repeated-dose intravenous subchronic toxicity test, but these variations remained within historically acceptable ranges. No skin or tissue irritation was observed in the maximum value assay and intradermal reaction assay. Genotoxicity of the PVA microspheres was not observed in either the bacterial reverse mutation assay or the mouse lymphoma cell mutation assay.
PVA microspheres exhibit good biocompatibility both in vivo and in vitro, making them an ideal embolization material for drug-loaded microsphere transarterial chemoembolization (DEB-TACE) therapy.
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