Chinese Journal of Tissue Engineering Research ›› 2020, Vol. 24 ›› Issue (34): 5564-5569.doi: 10.3969/j.issn.2095-4344.2343

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Immunogenicity of heterogeneous acellular biosurgical patch

Cheng Xiang1, Guo Huan1, Liu Yanping1, Wei Xiaohui2, Lei Dan2, Wu Tao1, Huang Ting1, Huang Ming1, Rong Zuyuan1, Ling You2    

  1. 1Sichuan Institute for Food and Drug Control, Chengdu 611731, Sichuan Province, China; 2Guanhao Biotech Co., Ltd., National Engineering Laboratory for Regenerative Implantable Medical Devices, Guangzhou 510530, Guangdong Province, China

  • Received:2019-12-23 Revised:2019-12-27 Accepted:2020-02-26 Online:2020-11-08 Published:2020-09-11
  • Contact: Rong Zuyuan, Researcher, Sichuan Institute for Food and Drug Control, Chengdu 611731, Sichuan Province, China Ling You, PhD, Guanhao Biotech Co., Ltd., National Engineering Laboratory for Regenerative Implantable Medical Devices, Guangzhou 510530, Guangdong Province, China
  • About author:Cheng Xiang, Master, Sichuan Institute for Food and Drug Control, Chengdu 611731, Sichuan Province, China
  • Supported by:
    the Scientific Research Project of Sichuan Institute for Food and Drug Control, No. 2018-KYYL-008; the National Key Research &Development Program of China, No. 2018YFC1105902

Abstract:

BACKGROUND: Since the removal of immunogenicity of heterogeneous acellular patch is directly related to the success of the implantation into human body, it is vital to evaluate the immunogenicity of the material.

OBJECTIVE: To evaluate the immunogenicity of heterogeneous acellular surgical path.

METHODS: Twenty Balb/c mice were randomly divided into four groups (n=5 per group). Mice in the experimental group and control group were subcutaneously implanted with heterogeneous acellular biosurgical patch and pericardium on the back. Negative controls received sham operation. Mice in the positive control group received subcutaneous injection of the mixture of Freund’s adjuvant and bovine serum albumin in equal volumes. At 4 weeks after implantation, the body weight of mice was recorded; the coefficients of spleen and thymus were calculated; the level of total serum IgG and IgM, the proliferation activity of lymphocytes in vitro and the distribution of lymphocyte subtypes in the spleen were measured; and the histopathology of the skin, spleen and thymus was observed. The experiment was approved by the Laboratory Animal Management and Use Committee of Safety Evaluation Center, Sichuan Institute for Food and Drug Control (approval No. IACUC-2018-KYYL-008).  

RESULTS and CONCLUSION: (1) There were no significant changes in the mouse body weight between the experimental group and negative control group (P > 0.05). Body weight was higher in the control group than in the negative control group (P < 0.05). (2) There was no significant difference in the brain ratios of spleen and thymus between the experimental group and the negative control group (P > 0.05). The brain ratio of spleen was higher in the control group than in the negative control group (P < 0.05). (3) There was no significant difference in lymphocyte proliferation between the experimental group and the negative control group (P > 0.05). Lymphocyte proliferation was higher in the control group than in the negative control group (P < 0.05). (4) Compared with the negative control group, the percentage of CD3+CD8+ cells was significantly decreased in the experimental group (P < 0.05). Compared with the negative control group, the percentages of CD3+ cells, CD3+CD4+ cells, CD3+CD8+ cells, and CD45+SSClow cells were decreased (P < 0.05) and the percentage of CD3-CD19+ cells was increased (P < 0.05) in the control group. (5) There was no significant difference in serum IgM and IgG antibody levels between the experimental and control groups and the negative control group (P < 0.05). (6) The histological examination results showed that there were no obvious pathological changes in the spleen and thymus in the experimental group and the control group, and no obvious inflammatory reaction in the experimental group. In the control group, there were severe granulomatous inflammation, fibrous tissue hyperplasia, wrapping, necrosis and disintegration of implants. (7) The results demonstrated that compared with the raw material, the immunogenicity of acellular treated biosurgical patch could be reduced effectively.

Key words: materials">,  , acellular, patch">,  , immunogenicity">,  , pericardium">,  , spleen">,  , thymus">,  , lymphocyte">,  , antibody

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