Biocompatibility of a New Kind of Polyvinyl Alcohol Embolic Microspheres: In Vitro and In Vivo Evaluation.

ABSTRACT

The aim of this study is to investigate the biocompatibility of polyvinyl alcohol (PVA) embolic microspheres by in vivo and in vitro evaluations. Two specifications of PVA microspheres including colorless microspheres (1 g microspheres with 7 mL 0.9% sodium chloride (SC) per vial, size 500-700 µm) and blue microspheres (2 g microspheres with 7 mL 0.9% SC per vial, size 500-700 µm) were assessed for biocompatibility. The vitro cytotoxicity was evaluated in L929 cells by MTT assay. Acute systemic toxicity and 28-repeat dose intravenous subchronic toxicity were assessed in 20 ICR mice and 40 SD rates, respectively. Skin sensitization was conducted in 30 adult albino guinea pigs by maximization test, in addition, intracutaneous reaction test was performed in New Zealand white rabbits. Hemolysis ratio of PVA microspheres was evaluated with rabbit blood. Moreover, test for genotoxicity was assessed by bacterial reverse mutation test and mouse lymphoma mutagenesis assay. No cytotoxicity, hemolysis, or acute toxicity of PVA microspheres was found, and slight fluctuations of biochemical indexes were observed in test of 28-day repeat dose intravenous subchronic toxicity, while these changes remained within our historical permitted range. Maximization test and intracutaneous reactivity test disclosed no irritation to skin or tissues. According to bacterial reverse mutation test and mouse lymphoma mutagenesis assay, no genotoxicity of PVA microspheres was observed. PVA microspheres showed excellent biocompatibility both in vivo and in vitro, and they were promising embolic materials for drug-eluting beads transarterial chemoembolization (DEB-TACE) therapy.