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<i>In vivo</i> safety prediction of recombinant collagen using <i>in vitro</i> simulated degradation analysis, chronic toxicity and immunological evaluation.


ABSTRACT: Protein-based biomaterials, particularly collagen-derived materials, have been widely applied in medical devices and regenerative medicine due to their excellent biocompatibility and tissue repair-promoting functions. However, the degradation of these materials in vivo may trigger immune responses and other physiological reactions, especially through interactions between degradation products and the immune system. To better evaluate their safety and efficacy, particularly regarding the potential immunotoxicological risks posed by degradation products, this study proposes a comprehensive evaluation framework combining degradation product simulation, immunotoxicological assessment and chronic toxicity testing, aiming to more fully identify potential risks during the degradation proces

SUBMITTER: Huang C 

PROVIDER: S-EPMC12900536 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature