Carcinogenesis, Teratogenesis & Mutagenesis ›› 2025, Vol. 37 ›› Issue (2): 157-161.doi: 10.3969/j.issn.1004-616x.2025.02.011

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Immunological risk assessment of a porcine-derived absorbable anti-adhesion material

SHAO Anliang1, CHEN Liyuan1, FUJIKAWA Yoshiyuki2, YAGA Yuta2, CHEN Liang1   

  1. 1. National Institutes for Food and Drug Control, Beijing 102629;
    2. Gunze Medical Devices (Shenzhen) Limited, Shenzhen 518118, Guangdong, China
  • Received:2024-08-25 Revised:2024-12-10 Online:2025-03-30 Published:2025-04-11

Abstract: OBJECTIVE:To evaluate the immunological risk of a porcine-derived absorbable anti-adhesion material. METHODS:SPF-grade BALB/c mice were randomly divided into a blank control,a positive control,and a test material groups,with 20 mice in each group,equally divided by gender. The blank control group underwent surgical operations without the implantation of materials. The positive control group was subcutaneously injected with a mixture of bovine serum albumin and complete Freund's adjuvant in equal volumes,immunized once a week for a total of 4 times. The test material group was implanted subcutaneously with 7 cm2 of a porcine-derived absorbable anti-adhesion material on the back. After 4 and 8 weeks of implantation,10 mice from each group were sacrificed (equally divided by gender),and specimens such as mouse blood,spleen,thymus,and the implanted material and surrounding tissues were collected. Enzyme-linked immunosorbent assay (ELISA) was used to detect the total antibody levels in the serum. Cytokine Bead Assay detection technology was used to detect the levels of serum cytokines IFN-γ,IL-6,and IL-12p70. The CCK8 method was used to detect the proliferation level of lymphocytes. And an electronic balance was used to weigh the spleen and thymus,and HE staining was used to analyze the histopathology of the spleen,thymus,and local implanted material tissues. RESULTS:Compared with the blank control group,the test material group showed no statistically significant differences in total antibody levels,cytokine expression levels,lymphocyte proliferation,immune organ weight and coefficient (P>0.05). After 4 weeks of implantation,the tissue sections of the test material group mice showed some irregularly red-staining around the implants,with a histological score of 27.7 points. After 8 weeks of implantation,no implants were seen in the tissue sections of the test material group mice,with a histological score of 3.4 points. CONCLUSION:In this study,the subcutaneous implantation of the porcine-derived absorbable anti-adhesion material did not cause significant adverse effects on the immune system of mice,and the risk of immunotoxicity is low.

Key words: porcine-derived absorbable anti-adhesion material, immunological risk, local histopathology, mouse

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