Safety and tissue remodeling assay of small intestinal submucosa meshes using a modified porcine surgical hernia model
In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known about the function of the immunogenic residual, absorbable profile during the tissue repair process. Moreover, there needs to be a recognized preclinical...
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Published in | Scientific reports Vol. 13; no. 1; p. 23108 |
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03.01.2024
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Abstract | In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known about the function of the immunogenic residual, absorbable profile during the tissue repair process. Moreover, there needs to be a recognized preclinical animal model to investigate the safety and efficacy of extracellular matrix meshes. Herein, we designed and fabricated a kind of SIS mesh followed by a scanned electron micrograph characterization and tested α-Gal antigen clearance rate and DNA residual. In order to prove the biocompatibility of the SIS mesh, cell viability, chemotaxis assay and local tissue reaction were assessed by MTT and RTCA cytotoxicity test in vitro as well as implantation and degradation experiments in vivo. Furthermore, we developed a stable preclinical animal model in the porcine ventral hernia repair investigation, which using laparoscopic plus open hybridization method to evaluate tissue adhesion, explant mechanical performance, and histologic analysis after mesh implantation. More importantly, we established a semi-quantitative scoring system to examine the ECM degradation, tissue remodeling and regeneration in the modified porcine surgical hernia model for the first time. Our results highlight the application prospect of the improved porcine ventral hernia model for the safety and efficacy investigation of hernia repair meshes. |
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AbstractList | In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known about the function of the immunogenic residual, absorbable profile during the tissue repair process. Moreover, there needs to be a recognized preclinical animal model to investigate the safety and efficacy of extracellular matrix meshes. Herein, we designed and fabricated a kind of SIS mesh followed by a scanned electron micrograph characterization and tested α-Gal antigen clearance rate and DNA residual. In order to prove the biocompatibility of the SIS mesh, cell viability, chemotaxis assay and local tissue reaction were assessed by MTT and RTCA cytotoxicity test in vitro as well as implantation and degradation experiments in vivo. Furthermore, we developed a stable preclinical animal model in the porcine ventral hernia repair investigation, which using laparoscopic plus open hybridization method to evaluate tissue adhesion, explant mechanical performance, and histologic analysis after mesh implantation. More importantly, we established a semi-quantitative scoring system to examine the ECM degradation, tissue remodeling and regeneration in the modified porcine surgical hernia model for the first time. Our results highlight the application prospect of the improved porcine ventral hernia model for the safety and efficacy investigation of hernia repair meshes. Abstract In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known about the function of the immunogenic residual, absorbable profile during the tissue repair process. Moreover, there needs to be a recognized preclinical animal model to investigate the safety and efficacy of extracellular matrix meshes. Herein, we designed and fabricated a kind of SIS mesh followed by a scanned electron micrograph characterization and tested α-Gal antigen clearance rate and DNA residual. In order to prove the biocompatibility of the SIS mesh, cell viability, chemotaxis assay and local tissue reaction were assessed by MTT and RTCA cytotoxicity test in vitro as well as implantation and degradation experiments in vivo. Furthermore, we developed a stable preclinical animal model in the porcine ventral hernia repair investigation, which using laparoscopic plus open hybridization method to evaluate tissue adhesion, explant mechanical performance, and histologic analysis after mesh implantation. More importantly, we established a semi-quantitative scoring system to examine the ECM degradation, tissue remodeling and regeneration in the modified porcine surgical hernia model for the first time. Our results highlight the application prospect of the improved porcine ventral hernia model for the safety and efficacy investigation of hernia repair meshes. Abstract In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known about the function of the immunogenic residual, absorbable profile during the tissue repair process. Moreover, there needs to be a recognized preclinical animal model to investigate the safety and efficacy of extracellular matrix meshes. Herein, we designed and fabricated a kind of SIS mesh followed by a scanned electron micrograph characterization and tested α-Gal antigen clearance rate and DNA residual. In order to prove the biocompatibility of the SIS mesh, cell viability, chemotaxis assay and local tissue reaction were assessed by MTT and RTCA cytotoxicity test in vitro as well as implantation and degradation experiments in vivo. Furthermore, we developed a stable preclinical animal model in the porcine ventral hernia repair investigation, which using laparoscopic plus open hybridization method to evaluate tissue adhesion, explant mechanical performance, and histologic analysis after mesh implantation. More importantly, we established a semi-quantitative scoring system to examine the ECM degradation, tissue remodeling and regeneration in the modified porcine surgical hernia model for the first time. Our results highlight the application prospect of the improved porcine ventral hernia model for the safety and efficacy investigation of hernia repair meshes. |
ArticleNumber | 23108 |
Author | Gai, Xiaoxiao Sun, Xiaoxia Lin, Zhenhua Zhang, Jian Ruan, Wenting Liu, Chenghu Zhu, Fuyu Qu, Qiujin Wang, Changbin |
Author_xml | – sequence: 1 givenname: Chenghu surname: Liu fullname: Liu, Chenghu organization: Institute of Immunopharmacology and Immunotherapy, School of Pharmaceutical Sciences, Shandong University, Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 2 givenname: Zhenhua surname: Lin fullname: Lin, Zhenhua organization: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 3 givenname: Wenting surname: Ruan fullname: Ruan, Wenting organization: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 4 givenname: Xiaoxiao surname: Gai fullname: Gai, Xiaoxiao organization: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 5 givenname: Qiujin surname: Qu fullname: Qu, Qiujin organization: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 6 givenname: Changbin surname: Wang fullname: Wang, Changbin organization: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 7 givenname: Fuyu surname: Zhu fullname: Zhu, Fuyu organization: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 8 givenname: Xiaoxia surname: Sun fullname: Sun, Xiaoxia organization: Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices – sequence: 9 givenname: Jian surname: Zhang fullname: Zhang, Jian email: zhangj65@sdu.edu.cn organization: Institute of Immunopharmacology and Immunotherapy, School of Pharmaceutical Sciences, Shandong University |
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Snippet | In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known about the... Abstract In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known... Abstract In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known... |
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SubjectTerms | 631/61/2035 692/4017 Animal models Animals Biocompatibility Cell viability Chemotaxis Cytotoxicity Extracellular matrix Hernia Hernia, Ventral - surgery Hernias Herniorrhaphy - methods Humanities and Social Sciences Hybridization Immunogenicity Laparoscopy Models, Animal multidisciplinary Prostheses and Implants Safety Science Science (multidisciplinary) Small intestine Swine Tissues Wound Healing |
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Title | Safety and tissue remodeling assay of small intestinal submucosa meshes using a modified porcine surgical hernia model |
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