Assessment of the Toxicity of Biocompatible Materials Supporting Bone Regeneration: Impact of the Type of Assay and Used Controls

Abstract

Assessing the toxicity of new biomaterials dedicated to bone regeneration can be difficult. Many reports focus only on a single toxicity parameter, which may be insufficient for a detailed evaluation of the new material. Moreover, published data frequently do not include control cells exposed to the environment without composite or its extract. Here we present the results of two assays used in the toxicological assessment of materials’ extracts (the integrity of the cellular membrane and the mitochondrial activity/proliferation), and the influence of different types of controls used on the obtained results. Results obtained in the cellular membrane integrity assay showed a lack of toxic effects of all tested extracts, and no statistical differences between them were present. Control cells, cells incubated with chitosan extract or chitosan-bioglass extract were used as a reference in proliferation calculations to highlight the impact of controls used on the result of the experiment. The use of different baseline controls caused variability between obtained proliferation results, and influenced the outcome of statistical analysis. Our findings confirm the thesis that the type of control used in an experiment can change the final results, and it may affect the toxicological assessment of biomaterial.

Effect of Selected Crosslinking and Stabilization Methods on the Properties of Porous Chitosan Composites Dedicated for Medical Applications

“…All biological assays in this study were performed as described previously [27,28]. Methods are described briefly below:…”

Chitosan and Sodium Hyaluronate Hydrogels Supplemented with Bioglass for Bone Tissue Engineering

“…New biocomposites containing chitosan and bioglass have been found to be highly biocompatibile and have antimicrobial properties [12,13]. The assessment of the cytocompatibility of biocomposites for tissue regeneration can be achieved via both direct and indirect methods based on extracts prepared from the biomaterials to be tested [14,15]. Biomaterials intended to fill in bone tissue defects can cause side effects, that is, hypersensitivity, chronic inflammation, or immunosuppression/rejection of implants [16,17].…”

Transient magnesium‐based thin‐film temperature sensor on a flexible, bioabsorbable substrate for future medical applications

“…[4,5] In addition, the used materials are not permitted to be toxic or to cause any immunological, physiological or mutagenic effect. [6][7][8][9][10] Typical biocompatible materials for implantable sensors are, for example, gold and platinum as well as polymers such as polyethylene glycol (PEG), polylactide acid (PLA), poly (vinyl alcohol) (PVA), chitosan, and fibroin. [11][12][13][14][15][16][17][18][19] Being at the same time biodegradable, however, further limits the materials in use.…”