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preclinical study of a self-expanding pulmonary valve for the treatment of pulmonary valve disease

Regenerative Biomaterials 2020年第6期7卷 609-618页

作者： Dajun Kuang Yang Lei Li Yang Yunbing Wang National Engineering Research Center for Biomaterials Sichuan UniversityNo 29 Wangjiang RoadChengdu 610064China Venus Medtech(Hangzhou)Inc. 88 Jiangling RoadHangzhou 311053China

In the past decade,balloon-expandable percutaneous pulmonary valves have been developed and applied in clinical ***,all the existing products of pulmonary artery interventional valves in the market have a straight structure design,and they require a preset support frame and balloon *** shape design of the valve limits the application *** addition,the age of the population with pulmonary artery disease is generally low,and the existing products cannot meet the needs of anti-calcification properties and valve material *** this study,through optimization of the support frame and leaflet design,a self-expanding pulmonary valve product with a double bell-shaped frame was designed to improve the match of the valve and the implantation site.A loading and deployment study showed that the biomaterial of the valve was not damaged after being *** flow and fatigue in vitro tests showed that the fabricated pulmonary valve met the hydrodynamic requirements after 2108 accelerated fatigue *** safety and efficacy of the pulmonary valve product were demonstrated in studies of pulmonary valve implantation in 11 *** and echocardiography showed that the pulmonary valves were implanted in a good position,and they had normal closure and acceptable valvular *** 180 days’implantation results showed that the calcium content was 0.31-1.39 mg/g in the anti-calcification treatment group,which was significantly lower than that in the control valve without anti-calcification treatment(16.69 mg/g).Our new interventional pulmonary valve product was ready for clinical trials and product registration.

关键词： pulmonary valve self-expanding double bell-shaped anti-calcification preclinical

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Non-human primate pluripotent stem cells for the preclinical testing of regenerative therapies

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Neural Regeneration Research 2022年第9期17卷 1867-1874页

作者： Ignacio Rodríguez-Polo Rüdiger Behr Research Platform Degenerative Diseases German Primate Center-Leibniz Institute for Primate ResearchGöttingenGermany German Center for Cardiovascular Research(DZHK) Partner Site GöttingenGöttingenGermany

Non-human primates play a key role in the preclinical validation of pluripotent stem cell-based cell replacement *** stem cells used as advanced therapy medical products boost the possibility to regenerate tissues and organs affected by degenerative ***,the methods to derive human induced pluripotent stem cell and embryonic stem cell lines following clinical standards have quickly developed in the last 15 *** the preclinical validation of cell replacement therapies in non-human primates,it is necessary to generate non-human primate pluripotent stem cell with a homologous quality to their human ***,pluripotent stem cell technologies have developed at a slower pace in non-human primates in comparison with human cell *** recent years,however,relevant progress has also been made with non-human primate pluripotent stem *** review provides a systematic overview of the progress and remaining challenges for the generation of non-human primate induced pluripotent stem cells/embryonic stem cells for the preclinical testing and validation of cell replacement *** focus on the critical domains of(1)reprogramming and embryonic stem cell line derivation,(2)cell line maintenance and characterization and,(3)application of non-human primate pluripotent stem cells in the context of selected preclinical studies to treat cardiovascular and neurodegenerative disorders performed in non-human primates.

关键词： embryonic stem cells induced pluripotent stem cells non-human primates pluripotent stem cells preclinical regeneration reprogramming translational research

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Capacity of human umbilical cord-derived mesenchymal stem cells to differentiate into sweat gland-like cells:a preclinical study

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Frontiers of Medicine 2013年第3期7卷 345-353页

作者： Siming Yang Kui Ma Changjiang Feng Yan Wu Yao Wang Sha Huang Xiaobing Fu Institute of Basic Medical Sciences PLA General Hospitalthe PLA Medical CollegeBeijing 100853China Burns Institute the First Affiliated HospitalPLA General HospitalBeijing 100048China

Human umbilical cord-derived mesenchymal stem cells(hUC-MSCs)possess various advantageous properties,including self-renewal,extended proliferation potential,multi-lineage differentiation potential and capacity for differentiating into sweat gland-like cells in certain ***,little is known about the effect of clinical-grade culture conditions on these properties and on the differentiative potential of *** this study,we sought to investigate the properties of hUC-MSCs expanded with animal serum free culture media(ASFCM)in order to determine their potential for differentiation into sweat gland-like *** found that primary cultures of hUC-MSCs could be established with ***,cells cultured in ASFCM showed vigorous proliferation comparable to those of cells grown in classical culture conditions containing fetal bovine serum(FBS).Morphology of hUC-MSCs cultured in ASFCM was comparable to those of cells grown under classical culture conditions,and hUC-MSCs grown in both of the two culture conditions tested showed the typical antigen profile of MSCs—positive for CD29,CD44,CD90,and CD105,and negative for CD34 and CD45,as *** aberration assay revealed that the cells were stable after long-term culture under both culture *** normal cultured MSCs,hUC-MSCs induced under ASFCM conditions exhibited expression of the same markers(CEA,CK14 and CK19)and developmental genes(EDA and EDAR)that are characteristic of normal sweat gland *** together,our findings indicate that the classical culture medium used to differentiate hUC-MSCs into sweat gland-like cells can be replaced safely by ASFCM for clinical purposes.

关键词： umbilical cord mesenchymal stem cells sweat gland preclinical

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Discovery and preclinical development of ⅢM-160, a Bergenia ciliatabased anti-inflammatory and anti-arthritic botanical drug candidate

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Journal of Integrative Medicine 2019年第3期17卷 192-204页

作者： Sandip B.Bharate Vikas Kumar Sonali S.Bharate Bikarma Singh Gurdarshan Singh Amarinder Singh Mehak Gupta Deepika Singh Ajay Kumar Surjeet Singh Ram A.Vishwakarma Medicinal Chemistry Division Indian Institute of Integrative Medicine Council of Scientific and Industrial Research PK-PD Toxicology & Formulation Division Indian Institute of Integrative Medicine Council of Scientific and Industrial Research Biodiversity and Applied Botany Division Indian Institute of Integrative Medicine Council of Scientific and Industrial Research Quality Control and Quality Assurance Division Indian Institute of Integrative Medicine Council of Scientific and Industrial Research

Objective: Bergenia ciliata(Haw.) Sternb. is used in the Indian traditional system of medicine to treat various ailments including rheumatism and to heal wounds. The objective of the present study was to perform a preclinical characterization of the B. ciliata-based botanical extract ***: ⅢM-160 was chemically standardized and analyzed for heavy metal content, aflatoxins,pesticides and microbial load. The in vitro and in vivo efficacies were determined in suitable models of inflammation, arthritis and nociception. An acute oral toxicity study was performed in Swiss albino mice.A suitable oral formulation was developed and ***: Bergenin was found to be the major component(9.1% w/w) of ⅢM-160. The botanical lead displayed inhibition of lipopolysaccharide-induced production of proinflammatory cytokines in THP-1 cells, with selectivity toward interleukin-6(IL-6) and had an excellent safety-window. It showed anti-inflammatory, anti-arthritic and antinociceptive activity in animal models and was not toxic at oral doses up to 2 g/kg in Swiss-albino mice. The gastroretentive, sustained-release capsule formulation showed sustained-release of the bergenin over the period of 24 h, resulting in improved plasma-exposure of bergenin in Sprague–Dawley ***: The dual-activity of IL-6 inhibition and antinociception marks the suitability of ⅢM-160 for treating rheumatoid arthritis. This study will serve as the benchmark for further research on this botanical formulation.

关键词： Botanical preclinical candidate UIM-160 Bergenia ciliata Arthritis Gastroretentive sustained release formulation Bergenin

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Bioartificial liver support systems for acute liver failure: A systematic review and meta-analysis of the clinical and preclinical literature

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World Journal of Gastroenterology 2019年第27期25卷 3634-3648页

作者： Yu-Ting He Ya-Na Qi Bing-Qi Zhang Jian-Bo Li Ji Bao Laboratory of Pathology Key Laboratory of Transplant Engineering and ImmunologyNHCWest China HospitalSichuan UniversityChengdu 610041Sichuan ProvinceChina Chinese Evidence-based Medicine Center West China HospitalSichuan UniversityChengdu 610041Sichuan ProvinceChina Department of Liver Surgery West China HospitalSichuan UniversityChengdu 610041Sichuan ProvinceChina

BACKGROUND Acute liver failure(ALF) has a high mortality varying from 80% to 85% with rapid progress in multi-organ system failure. Bioartificial liver(BAL) support systems have the potential to provide temporary support to bridge patients with ALF to liver transplantation or spontaneous recovery. In the past decades, several BAL support systems have been conducted in clinical trials. More recently,concerns have been raised on the renovation of high-quality cell sources and configuration of BAL support systems to provide more benefits to ALF models in preclinical *** To investigate the characteristics of studies about BAL support systems for ALF,and to evaluate their effects on *** Eligible clinical trials and preclinical experiments on large animals were identified on Cochrane Library, PubMed, and EMbase up to March 6, 2019. Two reviewers independently extracted the necessary information, including key BAL indicators, survival and indicating outcomes, and adverse events during treatment. Descriptive analysis was used to identify the characteristics of the included studies, and a meta-analysis including only randomized controlled trial (RCT) studies was done to calculate the overall effect of BAL on mortality among humans and large animals, *** Of the 30 selected studies, 18 were clinical trials and 12 were preclinical experiments. The meta-analysis result suggested that BAL might reduce mortality in ALF in large animals, probably due to the recent improvement of BAL, including the type, cell source, cell mass, and bioreactor, but seemed ineffective for humans (BAL vs control: relative risk(95% confidence interval),0.27(0.12-0.62) for animals and 0.72(0.48-1.08) for humans)Liver and renal functions, hematologic and coagulative parameters, encephalopathy index, and neurological indicators seemed to improve after BAL, with neither meaningful adverse events nor porcine endogenous retrovirus *** BAL may reduce

关键词： Bioartificial liver Acute liver failure preclinical experiment Clinical trial Meta-analysis

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Comparison of gene expression in cynomolgus monkeys with preclinical type Ⅱ diabetes induced by different high energy diets

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Animal Models and Experimental Medicine 2019年第1期2卷 44-50页

作者： Li-Sha Jin Jun-Hua Rao Li-Biao Zhang Fang Ji Yan-Chun Zhang Xiang-Fen Hao Bai-Lu Peng Xiao-Ming Liu Yun-Xiao Sun Guangdong Key Laboratory of Animal Conservation and Resource Utilization Guangdong Public Laboratory of Wild Animal Conservation and UtilizationGuangdong Institute of Applied Biological Resources South China Botanical Garden

Background : Cynomolgus disease models that are similar to the preclinical stage of human type 2 diabetes mellitus(T2 DM) were established by feeding middle-aged cynomolgus monkeys different high energy diets to study the differential expression of diabetes-related genes. Methods : A total of 36 male monkeys were randomly divided into four groups and fed human diets with high sugar, high fat, double high sugar and fat, and a normal diet. The preclinical diabetes phase was determined by monitoring the metabolic characteristic indices and the results of oral glucose tolerance tests( OGTT). The mRNA expression of 45 diabetes-related genes in peripheral blood leukocytes was analyzed using real-time PCR. Results : A total of 22, 25, and 21 genes were significantly up-regulated( P < 0.05) and 5, 7, and 5 genes were significantly down-regulated( P < 0.05) in the above three induced groups, respectively, compared with the control group. Of the 45 tested genes, the expression profiles of 21 genes were consistent. Most of the expression levels in the double high sugar-and-fat individuals were slightly lower than those in the high glucose and high fat groups, although the expression patterns of the three groups were essentially similar. Conclusion : The different high energy diets all induced diabetes and shared some phenotypic properties with human T2 DM. Most of the expression patterns of the related genes were identical. The gene expression profiles could be used as references for the study of early diagnostic indicators and T2 DM pathogenesis.

关键词： cynomolgus monkey gene expression high energy diet preclinical phase type 2 diabetes

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Advances in preclinical evaluation of experimental antibody-drug conjugates

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Cancer Drug Resistance 2021年第4期4卷 745-754页

作者： Scott K.Lyons Dennis Plenker Lloyd C.Trotman Cold Spring Harbor Laboratory Cold Spring HarborNY 11724USA

The ability to chemically modify monoclonal antibodies with the attachment of specific functional groups has opened up an enormous range of possibilities for the targeted treatment and diagnosis of cancer in the *** the number of such antibody-based drug candidates has increased,so too has the need for more stringent and robust preclinical evaluation of their in vivo performance to maximize the likelihood that time,research effort,and money are only spent developing the most effective and promising candidate molecules for translation to the *** with the development of antibody-drug conjugate(ADC)technology,several recent advances in preclinical research stand to greatly increase the experimental rigor by which promising candidate molecules can be *** include advances in preclinical tumor modeling with the development of patient-derived tumor organoid models that far better recapitulate many aspects of the human disease than conventional subcutaneous xenograft *** models are amenable to genetic manipulation,which will greatly improve our understanding of the relationship between ADC and antigen and stringently evaluate mechanisms of therapeutic ***,tumor development is often not visible in these in vivo *** discuss how the application of several preclinical molecular imaging techniques will greatly enhance the quality of experimental data,enabling quantitative pre-and post-treatment tumor measurements or the precise assessment of ADCs as effective *** our opinion,when taken together,these advances in preclinical cancer research will greatly improve the identification of effective candidate ADC molecules with the best chance of clinical translation and cancer patient benefit.

关键词： Antibody-drug conjugate tumor preclinical organoid CRISPR preclinical imaging theranostic

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preclinical transplantation and safety of HS/PCs expanded from human umbilical cord blood

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World Journal of Stem Cells 2011年第5期3卷 43-52页

作者： Chun-Juan Guo Ying Gao Di Hou Dong-Yan Shi Xiang-Min Tong Dan Shen Yong-Mei Xi Jin-Fu Wang Chun-Juan Guo Di Hou Dong-Yan Shi Yong-Mei Xi Jin-Fu Wang College of Life Sciences Zhejiang University Hangzhou 310058 Zhejiang Province China.

AIM: To expand hematopoietic/progenitor stem cells (HS/PCs) from umbilical cord blood (UCB) and prepare the HS/PC product, and analyze preclinical transplantation and safety of HS/PC product. METHODS: Human bone marrow-derived mesenchymal stem cells (MSCs) were used as feeder cells to expand HS/PCs from UCB in a serum-free culture system. The proliferation potential of HS/PCs was analyzed. The expanded HS/PCs were suspended in the L-15 medium to prepare the HS/PC product. The contamination of bacteria, fungi and mycoplasmas, the infection of exogenous virus, the concentration of bacterial endotoxin, and the SCF residual in HS/PC product were determined. Finally, cells from the HS/PC product with or without bone marrow-derived mesenchymal stem cells (BM-MSCs) were transplanted into the irradiated NOD/SCID mice to determine the in vivo engraftment potential. RESULTS: After co-culture for 10 d, the total nuclear cells (TNCs) increased 125-fold, and CD34 + cells increased 43-fold. The granulocyte-macrophage colonyforming cells (GM-CFCs) and erythroid colony-forming cells (E-CFCs) increased 3.3and 4.7-fold respectively. The expanded cells were collected and prepared as the expanded product of HS/PCs by re-suspending cells in L-15 medium. For preclinical safety, the HS/PC product was analysed for contamination by bacteria, fungi and mycoplasmas, the bacterial endotoxin concentration and the SCF content. The results showed that the HS/PC product contained no bacteria, fungi or mycoplasmas. The bacterial endotoxin concentration was less than the detection limit of 6 EU/mL, and residual SCF was 75 pg/mL. Based on clinical safety, the HS/PC product was qualified for clinical transplantation. Finally, the HS/PC product was transplanted the irradiated mice where it resulted in rapid engraftment of hematopoietic cells. CONCLUSION: HSPC product prepared from UCB in the serum-free culture system with hMSCs as feeder cells should be clinically safe and effective for clinical transp

关键词： Hematopoietic stem cells Ex vivo expansion preclinical safeties Transplantation

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preclinical experimental models of drug metabolism and disposition in drug discovery and development

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Acta Pharmaceutica Sinica B 2012年第6期2卷 549-561页

作者： Donglu Zhang Gang Luo Xinxin Ding Chuang Lu Bristol-Myer Squibb PrincetonNJ 08543USA Covance Laboratories MadisonWI 53704USA Wadsworth Center New York State Department of HealthAlbanyNY 12201USA Millennium Pharmaceuticals Inc.CambridgeMA 02139USA

Drug discovery and development involve the utilization of in vitro and in vivo ex perimental *** models,ranging from test tube experiments to cell cultures,animals,healthy human subjects,and even small numbers of patients that are involved in clinical trials,are used at different stages of drug discovery and development for determination of efficacy and *** proper selection and applications of correct models,as well as appropriate data interpretation,are critically important in decision making and succesful advancement of drug *** this review,we discuss strategies in the applications of both in vitro and in *** models of drug metabolism and disposition.

关键词： preclinical In vitro model Drug metabolism and disposition ADME Engineered mouse model Caco-2 Hepatocytes Mass balance

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preclinical stem cell therapy in Chagas Disease: Perspectives for future research

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World Journal of Transplantation 2013年第4期3卷 119-126页

作者： Katherine Athayde Teixeira de Carvalho Eltyeb Abdelwahid Reginaldo Justino Ferreira Ana Carolina Irioda Luiz Cesar Guarita-Souza Cell Therapy and Biotechnology in Regenerative Medicine Research Group Pequeno Príncipe FacultyPelé Pequeno Príncipe InstituteCuritiba 80250-200ParanáBrazil Bioprocess Engineering and Biotechnology Department Federal University of ParanáCuritiba 81531-970ParanáBrazil CBRC Massachusetts General Hospital/Harvard Medical SchoolCharlestownMa 02129United States Federal University of Technology Curitiba 80230-901ParanáBrazil Experimental Laboratory of Institute of Biological and Health Sciences of Pontifical Catholic University of Parana Curitiba 80215-901ParanáBrazil

Chagas cardiomyopathy still remains a challenging problem that is responsible for high morbidity and mortality in Central and Latin America. Chagas disease disrupts blood microcirculation via various autoimmune mechanisms, causing loss of cardiomyocytes and severe impairment of heart function. Different cell types and delivery approaches in Chagas Disease have been studied in both preclinical models and clinical trials. The main objective of this article is to clarify the reasons why the benefits that have been seen with cell therapy in preclinical models fail to translate to the clinical setting. This can be explained by crucial differences between the cellular types and pathophysiological mechanisms of the disease, as well as the differences between human patients and animal models. We discuss examples that demonstrate how the results from preclinical trials might have overestimated the efficacy of myocardial regeneration therapies. Future research should focus, not only on studying the best cell type to use but, very importantly, understanding the levels of safety and cellular interaction that can elicit efficient therapeutic effects in human tissue. Addressing the challenges associated with future research may ensure the success of stem cell therapy in improving preclinical models and the treatment of Chagas disease.

关键词： Chagas Disease preclinical stem cell therapy co-cultured translation pathophysiologie myoblasts

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