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| 1 | Regulatory science for hernia mesh: Current status and future perspectives显示文摘Regulatory science for medical devices aims to develop new tools,standards and approaches to assess the safety,effectiveness,quality and performance of medical devices.In the field of biomaterials,hernia mesh is a class of implants that have been successfully translated to clinical applications.With a focus on hernia mesh and its regulatory science system,this paper collected and reviewed information on hernia mesh products and biomaterials in both Chinese and American markets.The current development of regulatory science for hernia mesh,including its regulations,standards,guidance documents and classification,and the scientific evaluation of its safety and effectiveness was first reported.Then the research prospect of regulatory science for hernia mesh was discussed.New methods for the preclinical animal study and new tools for the evaluation of the safety and effectiveness of hernia mesh,such as computational modeling,big data platform and evidence-based research,were assessed.By taking the regulatory science of hernia mesh as a case study,this review provided a research basis for developing a regulatory science system of implantable medical devices,furthering the systematic evaluation of the safety and effectiveness of medical devices for better regulatory decision-making.This was the first article reviewing the regulatory science of hernia mesh and biomaterial-based implants.It also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time. | Wenbo Liu Yajie Xie Yudong Zheng Wei He Kun Qiao Haoye Meng | 2021 | Bioactive Materials2021，6，2： | 5 |
| 2 | A novel bioactive polyurethane with controlled degradation and L-Arg release used as strong adhesive tissue patch for hemostasis and promoting wound healing显示文摘Effective strategy of hemostasis and promoting angiogenesis are becoming increasingly urgent in modern medicine due to millions of deaths caused by tissue damage and inflammation. The tissue adhesive has been favored as an optimistic and efficient path to stop bleeding, while, current adhesive presents limitations on wound care or potential degradation safety in clinical practice. Therefore, it is of great clinical significance to construct multifunctional wound adhesive to address the issues. Based on pro-angiogenic property of L-Arginine (L-Arg), in this study, the novel tissue adhesive (G-DLPUs) constructed by L-Arg-based degradable polyurethane (DLPU) and GelMA were prepared for wound care. After systematic characterization, we found that the G-DLPUs were endowed with excellent capability in shape-adaptive adhesion. Moreover, the L-Arg released and the generation of NO during degradation were verified which would enhance wound healing. Following the in vivo biocompatibility was verified, the hemostatic effect of the damaged organ was tested using a rat liver hemor-rhage model, from which reveals that the G-DLPUs can reduce liver bleeding by nearly 75% and no obvious inflammatory cells observed around the tissue. Moreover, the wound care effect was confirmed in a mouse full-thickness skin defect model, showing that the hydrogel adhesive significantly improves the thickness of newly formed dermis and enhance vascularization (CD31 staining). In summary, the G-DLPUs are promising candidate to act as multifunctional wound care adhesive for both damaged organ and trauma. | Faxing Zou Yansen Wang Yudong Zheng Yajie Xie Hua Zhang Jishan Chen M.Irfan Hussain Haoye Meng Jiang Peng | 2022 | Bioactive Materials2022，7，11： | 2 |
| 3 | Acellular nerve xenografts based on supercritical extraction technology for repairing long-distance sciatic nerve defects in rats显示文摘Compared to conventional artificial nerve guide conduits (NGCs) prepared using natural polymers or synthetic polymers, acellular nerve grafts (ACNGs) derived from natural nerves with eliminated immune components have natural bionic advantages in composition and structure that polymer materials do not have. To further optimize the repair effect of ACNGs, in this study, we used a composite technology based on supercritical carbon dioxide (scCO_(2)) extraction to process the peripheral nerve of a large mammal, the Yorkshire pig, and obtained an innovative Acellular nerve xenografts (ANXs, namely, CD + scCO_(2) NG). After scCO_(2) extraction, the fat and DNA content in CD + scCO_(2) NG has been removed to the greatest extent, which can better supported cell adhesion and proliferation, inducing an extremely weak inflammatory response. Interestingly, the protein in the CD + scCO_(2) NG was primarily involved in signaling pathways related to axon guidance. Moreover, compared with the pure chemical decellularized nerve graft (CD NG), the DRG axons grew naturally on the CD + scCO_(2) NG membrane and extended long distances. In vivo studies further revealed that the regenerated nerve axons had basically crossed the CD + scCO_(2) NG 3 weeks after surgery. 12 weeks after surgery, CD + scCO_(2) NG was similar to autologous nerves in improving the quality of nerve regeneration, target muscle morphology and motor function recovery and was significantly better than hollow NGCs and CD NG. Therefore, we believe that the fully decellularized and fat-free porcine ACNGs may be the most promising “bridge” for repairing human nerve defects at this stage and for some time to come. | Shuai Wei Qian Hu Jianxiong Ma Xiu Dai Yu Sun Gonghai Han Haoye Meng Wenjing Xu Lei Zhang Xinlong Ma Jiang Peng Yu Wang | 2022 | Bioactive Materials2022，7，12： | 1 |
| 4 | Effects of tissue heterogeneity on trabecular micromechanics examined by microCT-based finite element analysis and digital volume correlation显示文摘Trabecular bone is natural material with heterogeneous tissue properties.The effect of tissue heterogeneity on the micromechanical behavior of trabecular bone is commonly evaluated by microCT-based finite element(microFE)analysis.Results from prior work remain inconclusive and lack of experimental validation.To address these issues,we combined microFE analysis with mechanical testing and microCT-based digital volume correlation(DVC),as a validation for the microFE approach.Porcine trabecular specimens were tested in compression as sequential microCT scans were taken.DVC was performed to extract“realistic”boundary conditions that were applied to microFE models,and to measure microstructural deformation and strain of the trabecular specimens.Heterogeneous and homogeneous microFE models of each trabecular specimen were created and compared with the experimentally measured microstructural displacement and strains.Results showed strong correlations between DVC-measured and microFE-predicted trabecular displacement and strain fields(R^(2)>0.9,p<0.05),regardless of heterogeneous or homogeneous material assignments.The heterogeneous and homogeneous models predicted similar magnitudes for maximum or minimum principal strains(R^(2)=1,p<0.05).However,incorporation of tissue heterogeneity decreased more than 16.5%in the overall stress level of the trabecular tissues.Regardless,very strong correlations were found between the heterogeneous and homogeneous model-predicted principal strains or stresses.These results together suggest that tissue heterogeneity may have little effect on microFE modeling of typical elastic displacement and strains in the trabecular bone,suggesting that homogeneous material models might be sufficient to predict general trabecular micromechanics. | Jizhi Fu Haoye Meng Changhao Zhang Youjun Liu Duanduan Chen Aiyuan Wang Russell P.Main Haisheng Yang | 2021 | Medicine in Novel Technology and Devices2021，，3： | 0 |
| 5 | Polylysine-decorated macroporous microcarriers laden with adipose-derived stem cells promote nerve regeneration in vivo显示文摘Cell transplantation is an effective strategy to improve the repair effect of nerve guide conduits(NGCs).However,problems such as low loading efficiency and cell anoikis undermine the outcomes.Microcarriers are efficient 3D cell culture scaffolds,which can also prevent cell anoikis by providing substrate for adhesion during transplantation.Here,we demonstrate for the first time microcarrier-based cell transplantation in peripheral nerve repair.We first prepared macroporous chitosan microcarriers(CSMCs)by the emulsion-phase separation method,and then decorated the CSMCs with polylysine(pl-CSMCs)to improve cell affinity.We then loaded the pl-CSMCs with adipose-derived stem cells(ADSCs)and injected them into electrospun polycaprolactone/chitosan NGCs to repair rat sciatic nerve defects.The ADSCs-laden pl-CSMCs effectively improved nerve regeneration as demonstrated by evaluation of histology,motor function recovery,electrophysiology,and gastrocnemius recovery.With efficient cell transplantation,convenient operation,and the multiple merits of ADSCs,the ADSCs-laden pl-CSMCs hold good potential in peripheral nerve repair. | Yi Sun Xiaoqi Chi Haoye Meng Mengjiao Ma Jing Wang Zhaoxuan Feng Qi Quan Guodong Liu Yansen Wang Yajie Xie Yudong Zheng Jiang Peng | 2021 | Bioactive Materials2021，6，11： | 0 |
| 6 | Dual-bionic regenerative microenvironment for peripheral nerve repair显示文摘Autologous nerve grafting serves is considered the gold standard treatment for peripheral nerve defects;however,limited availability and donor area destruction restrict its widespread clinical application.Although the performance of allogeneic decellularized nerve implants has been explored,challenges such as insufficient human donors have been a major drawback to its clinical use.Tissue-engineered neural regeneration materials have been developed over the years,and researchers have explored strategies to mimic the peripheral neural microenvironment during the design of nerve catheter grafts,namely the extracellular matrix(ECM),which includes mechanical,physical,and biochemical signals that support nerve regeneration.In this study,polycaprolactone/silk fibroin(PCL/SF)-aligned electrospun material was modified with ECM derived from human umbilical cord mesenchymal stem cells(hUMSCs),and a dual-bionic nerve regeneration material was successfully fabricated.The results indicated that the developed biomimetic material had excellent biological properties,providing sufficient anchorage for Schwann cells and subsequent axon regeneration and angiogenesis processes.Moreover,the dual-bionic material exerted a similar effect to that of autologous nerve transplantation in bridging peripheral nerve defects in rats.In conclusion,this study provides a new concept for designing neural regeneration materials,and the prepared dual-bionic repair materials have excellent auxiliary regenerative ability and further preclinical testing is warranted to evaluate its clinical application potential. | Yanjun Guan Zhiqi Ren Boyao Yang Wenjing Xu Wenjun Wu Xiangling Li Tieyuan Zhang Dongdong Li Shengfeng Chen Jun Bai Xiangyu Song Zhibo Jia Xing Xiong Songlin He Chaochao Li Fanqi Meng Tong Wu Jian Zhang Xiuzhi Liu Haoye Meng Jiang Peng Yu Wang | 2023 | Bioactive Materials2023，，8： | 0 |
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