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Mucus-penetrating nonviral gene vaccine processed in the epithelium for inducing advanced vaginal mucosal immune responses

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Acta Pharmaceutica Sinica B 2023年第3期13卷 1287-1302页

作者： Qunjie Bi Xu Song Yangyang Zhao Xueyi Hu Huan Yang Rongrong Jin Yu Nie national engineering research center for biomaterials College of Biomedical EngineeringSichuan UniversityChengdu 610041China nmpa key laboratory for quality research and control of tissue regenerative biomaterial&institute of regulatory science for medical devices&nmpa research Base of regulatory science for medical devices Sichuan UniversityChengdu 610041China

Establishment of vaginal immune defenses at the mucosal interface layer through gene vaccines promise to prevent infectious diseases among *** barriers composed of a flowing mucus hydrogel and tightly conjugated epithelial cells(ECs),which represent the main technical difficulties for vaccine development,reside in the harsh,acidic human vaginal *** from frequently employed viral vectors,two types of nonviral nanocarriers were designed to concurrently overcome the barriers and induce immune *** design concepts include the charge-reversal property(DRLS)to mimic a virus that uses any cells as factories,as well as the addition of a hyaluronic acid coating(HA/RLS)to directly target dendritic cells(DCs).With a suitable size and electrostatic neutrality,these two nanoparticles penetrate a mucus hydrogel with similar *** DRLS system expressed a higher level of the carried human papillomavirus type 16 L1 gene compared to HA/RLS in *** it induced more robust mucosal,cellular,and humoral immune ***,the DLRS applied to intravaginal immunization induced high IgA levels compared with intramuscularly injected DNA(naked),indicating timely protection against pathogens at the mucus *** findings also offer important approaches for the design and fabrication of nonviral gene vaccines in other mucosal systems.

关键词： Intravaginal gene delivery Nonviral gene vaccination Mucus penetration Epithelial processing Lipopeptide pH-sensitive Virus mimicking

regulatory perspectives of combination products

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Bioactive Materials 2022年第4期7卷 492-503页

作者： Jiaxin Tian Xu Song Yongqing Wang Maobo Cheng Shuang Lu Wei Xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang center for medical device Evaluation National Medical Products AdministrationBeijingChina nmpa key laboratory for quality research and control of tissue regenerative biomaterial&institute of regulatory science for medical devices&nmpa research Base of regulatory science for medical devices Sichuan UniversityChengduChina national engineering research center for biomaterials&College of Biomedical engineering Sichuan UniversityChengduChina center for Drug Evaluation National Medical Products AdministrationBeijingChina

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological *** product research and development,clinical translation as well as regulatory evaluation of combination products are complex and *** review firstly introduced the origin,definition and designation of combination *** areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then *** and clinical evaluation of combination products was ***,the research prospect of regulatory science for combination products was *** tools of computational modeling and simulation,novel technologies such as artificial intelligence,needs of developing new standards,evidence-based research methods,new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety,efficacy,quality and performance of combination *** together,the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

关键词： Combination products Definition Designation Safety and efficacy regulatory science

The morphology of hydroxyapatite nanoparticles regulates clathrinmediated endocytosis in melanoma cells and resultant anti-tumor efficiency

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Nano research 2022年第7期15卷 6256-6265页

作者： Hongfeng Wu Yuchen Hua Jinjie Wu Qin Zeng Xiao Yang Xiangdong Zhu Xingdong Zhang national engineering research center for biomaterials Sichuan UniversityChengdu 610064China nmpa key laboratory for quality research and control of tissue regenerative biomaterials&institute of regulatory science for medical devices&nmpa research Base of regulatory science for medical devices Sichuan UniversityChengdu 610064China research center for Materials Genome engineering Sichuan UniversityChengdu 610064China

Clathrin-mediated endocytosis plays a critical role for hydroxyapatite nanoparticles(HANPs)to enter tumor cells,induce mitochondrial apoptosis,and inhibit tumor *** study was aimed to investigate how the morphology of HANPs impacts the endocytosis of the particles in melanoma cells,and their anti-tumor effect by using in vitro cell experiments and in vivo tumor animal *** shapes of HANPs,including granular HANPs(G-HANPs),rod-like HANPs(R-HANPs),and needle-like HANPs(N-HANPs),were successfully prepared by wet chemical *** the three HANPs could be internalized into A375 melanoma cells as indicated by cellular transmission electron microscopy *** these HANPs,only G-HANPs induced morphological change of mitochondria and loss of mitochondrial membrane potential(Δψm),and exhibited the greatest intracellular internalization efficiency in the tumor ***,the results of immunofluorescence staining and western blotting indicated that the level of adaptin-2(AP2)protein was up-regulated by all the HANPs,and highest in G-HANPs treated A375 ***,in the tumor-bearing mouse model,we found that tumor growth was delayed by all the three HANPs,of which,G-HANPs delayed tumor growth most efficiently and presented a highest expression level of AP2 protein in tumor ***,this study suggested that the morphology of HANPs regulated their endocytosis efficiency and their effect to inhibit tumor *** work facilitates to direct the rational design of nano-materials for tumor therapy.

关键词： hydroxyapatite nanoparticles adaptin-2 protein morphology endocytosis anti-tumor effect

Hydroxyapatite nanoparticles drive the potency of Toll-like receptor 9 agonist for amplified innate and adaptive immune response

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Nano research 2022年第10期15卷 9286-9297页

作者： Qin Zeng Ruiqi Wang Yuchen Hua Hongfeng Wu Xuening Chen You-cai Xiao Qiang Ao Xiangdong Zhu Xingdong Zhang national engineering research center for biomaterials Sichuan UniversityChengdu 610064China nmpa key laboratory for quality research and control of tissue regenerative biomaterials&institute of regulatory science for medical devices&nmpa research Base of regulatory science for medical devices Sichuan UniversityChengdu 610064China College of Biomedical engineering Sichuan UniversityChengdu 610064China key laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province Sichuan UniversityChengdu 610041China

The potency of Toll-like receptor 9(TLR9)agonist to drive innate immune response was limited due to immune suppression or tolerance during TLR9 signaling activation in immune *** we addressed this problem by introducing hydroxyapatite nanoparticles(HANPs)to CpG ODN(CpG),a TLR9 *** study revealed that HANPs concentration and durationdependently reprogramed the immune response by enhancing the secretion of immunostimulatory cytokines(tumor necrosis factorα(TNFα)or IL-6)while reducing the production of immunosuppressive cytokine(IL-10)in macrophages in response to ***,the enhanced immune response benefited from increased intracellular Ca2+in macrophage by the addition of ***,we found exposure to HANPs impacted the mitochondrial function of macrophages in support of the synthesis of adenosine triphosphate(ATP),the production of nicotinamide adenine dinucleotide(NAD),and reactive oxygen species(ROS)in the presence or absence of *** vaccinated mice model,only one vaccination with a mixture of CpG,HANPs,and OVA,a model antigen,allowed the development of a long-lasting balanced humoral immunity in mice without any histopathological change in the local injection ***,this study revealed that HANPs could modulate the intracellular calcium level,mitochondrial function,and immune response in immune cells,and suggested a potential combination adjuvant of HANPs and TLR9 agonist for vaccine development.

关键词： hydroxyapatite nanoparticles Toll-like receptor 9 intracellular calcium mitochondrial function adaptive immune response

Sequential expression of miR-221-3p and miR-338-3p in Schwann cells as a therapeutic strategy to promote nerve regeneration and functional recovery

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Neural Regeneration research 2023年第3期18卷 671-682页

作者： Li-Li Wen Tian-Hao Yu Yi-Zhan Ma Xiao-Yan Mao Tian-Rang Ao Rabia Javed Hirotomo Ten Akira Matsuno Qiang Ao Department of tissue engineering School of Intelligent MedicineChina Medical UniversityShenyangLiaoning ProvinceChina The VIP Department School and Hospital of StomatologyLiaoning Provincial Key Laboratory of Oral DiseasesChina Medical UniversityShenyangLiaoning ProvinceChina Department of Oncology Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijingChina Department of Neurosurgery Teikyo University School of MedicineTokyoJapan nmpa key laboratory for quality research and control of tissue regenerative biomaterial&institute of regulatory science for medical device&national engineering research center for biomaterials Sichuan UniversityChengduSichuan ProvinceChina

The functional properties of endogenous Schwann cells(SCs)during nerve repair are *** the functional properties of SCs at different stages of nerve repair may have therapeutic benefit in improving the repair of damaged *** studies showed that miR-221-3p promotes the proliferation and migration of SCs,and miR-338-3p promotes the myelination of *** this study,we established rat models of sciatic nerve injury by bridging the transected sciatic nerve with a silicone *** injected a miR-221 lentiviral vector system together with a doxycycline-inducible Tet-On miR-338 lentiviral vector system into the cavity of nerve conduits of nerve stumps to sequentially regulate the biological function of endogenous SCs at different stages of nerve *** found that the biological function of SCs was sequentially regulated,the diameter and density of myelinated axons were increased,the expression levels of NF200 and myelin basic protein were increased,and the function of injured peripheral nerve was improved using this *** Target Prediction Database prediction,Nanopore whole transcriptome sequencing,quantitative PCR,and dual luciferase reporter gene assay results predicted and verified Cdkn1b and Nrp1 as target genes of miR-221-3p and miR-338-3p,respectively,and their regulatory effects on SCs were confirmed in *** conclusion,here we established a new method to enhance nerve regeneration through sequential regulation of biological functions of endogenous SCs,which establishes a new concept and model for the treatment of peripheral nerve *** findings from this study will provide direct guiding significance for clinical treatment of sciatic nerve injury.

关键词： cdkn1b miR-221 miR-338 miRNA nerve regeneration Nrp1 peripheral nerve injury regulation Schwann cells sequential expression