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Liu M.,Shanghai Clinical Research Center | Hu Q.,Independent Ethics Committee in Shanghai Clinical Research Center
Bioethics | Year: 2014

Biobanks are potential goldmines for genomics research. They have become increasingly common as a means to determine the relationship between lifestyle, environmental exposures and predisposition to genetic disease. More and more countries are developing massive national scale biobanks, including Iceland, the UK and Estonia. Now several large-scale regional and national biobanks are planned in China, such as Shanghai Biobank, which is defined as a key-element in Shanghai's twelfth five-year Development Plan of Science and Technology. It is imperative that the authors who are in charge of the ethical aspect of Shanghai Biobank discuss the ethical aspects of these biobanks up front. Currently there is a great deal of heterogeneity in the approaches to informed consent taken by different countries. In the article, after briefly introducing the biobanks in China, we focus on the three most common approaches: classical informed consent, tiered consent, and one-time general (or blanket) consent, and propose a version of the latter for China, based on compelling arguments. © 2012 John Wiley & Sons Ltd.

Deng H.,Shanghai JiaoTong University | Deng H.,Nanchang University | Gao Y.-B.,Shanghai JiaoTong University | Gao Y.-B.,Fudan University | And 4 more authors.
Histopathology | Year: 2012

Aims: The molecular mechanisms underlying proliferation and malignant transformation of hepatic progenitor cells (HPCs) remain largely unknown. The purpose of this study was to evaluate the correlation between the expression of deleted in malignant brain tumours 1 (DMBT1) and the biological behaviour of HPCs in different hepatitis B virus (HBV)-related human liver diseases. Methods and results: Expression of DMBT1 in HPCs was investigated by double immunofluorescence labelling in control-group and HBV-related liver diseases, including hepatitis, hepatocellular carcinoma (HCC), non-tumoral liver tissue away from HCC, non-tumoral cirrhotic tissue adjacent to HCC, and non-HCC cirrhosis. DMBT1-positive HPCs were isolated by laser capture microdissection and subjected to duplex polymerase chain reaction in order to detect homozygous deletion of DMBT1. The number of DMBT1-positive HPCs increased in direct proportion to inflammation severity. Loss of heterozygosity for DMBT1 was more frequent in HCC tumour area and non-tumoral cirrhotic tissue adjacent to HCC, compared with other HBV-related liver diseases (P<0.05). Conclusions: DMBT1 may play an important role in the proliferation of HPCs in HBV-related liver diseases. Moreover, down-expression of DMBT1 might enhance the risk of malignant transformation of HPCs. © 2011 Blackwell Publishing Limited.

Fan J.,East China University of Science and Technology | Fan J.,Shanghai Clinical Research Center | Cai H.,East China University of Science and Technology | Li Q.,Guangxi University | And 2 more authors.
Journal of Biotechnology | Year: 2012

Oxygen tension regulates the biological characteristics of hematopoietic stem and progenitor cells (HSPCs) by modulating intracellular reactive oxygen species (ROS). To better understand oxygen tension mechanism on HSPCs culture, gene expression analysis of human CD34 +CD38 - HSPCs was performed using microarrays. The CD34 +CD38 - HSPCs cultured under normoxia, hypoxia, or with N-acetyl cysteine (NAC, an ROS scavenger) were isolated for transcriptional profilings. Compared to normoxia group, 1 gene was up-regulated and 22 genes were down-regulated in hypoxia group, while 1 gene was up-regulated and 29 genes were down-regulated in NAC group. These differently expressed genes were involved in cell surface markers, blood activation and differentiation. The common down-regulated genes related to dendritic cells (DCs) maturation (CD80, CD86, and JAG1) were confirmed by real-time RT-PCR. Furthermore, the analysis of the phenotypes of DCs, including the DC-characteristic surface molecule CD1a, the costimulatory molecules CD80 and CD86, and HLA-DR, associated with the capacity of DCs to stimulate allogeneic T cells, showed that hypoxia-mediating ROS inhibited the potential of CD34 +CD38 - HSPCs differentiating to mature DCs. All these results demonstrated that hypoxia-reducing ROS down-regulated the genes driving CD34 +CD38 - HSPCs differentiation, which provides an interesting molecular hint to direct their development to DCs during cultures. © 2012 Elsevier B.V.

Lu C.,Central Laboratory | Liu G.,Central Laboratory | Jia J.,Central Laboratory | Gui Y.,Shanghai Clinical Research Center | And 4 more authors.
Biomedical Chromatography | Year: 2011

A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed to determine total N-acetylcysteine in human plasma. Mass spectrometric detection was achieved in positive electrospray ionization and multiple reaction monitoring mode. The mass transition pairs of N-acetylcysteine and the isotope-labeled internal standard d3-N-acetylcysteine were 164 → 122 and 167 → 123, respectively. The method was linear over the range of 10-5000ng/mL in human plasma. The adoption of trichloroacetic acid significantly enhanced the extraction recovery. The blank matrix was screened to minimize the influence of endogenous N-acetylcysteine. After being fully validated, the method was successfully applied to the pharmacokinetic and bioequivalent study of N-acetylcysteine after oral administration of 600mg tablets to 24 healthy Chinese volunteers. © 2010 John Wiley & Sons, Ltd.

Xu J.,Shanghai Clinical Research Center | Liu M.,Shanghai Clinical Research Center | Xia Z.,Fudan University
Journal of Evidence-Based Medicine | Year: 2013

As human civilization develops, biomedicine stays robust. Faced with the challenge of Europe Union's Traditional Herbal Medicinal Products Directive, if traditional Chinese medicine (TCM) wants to be still used as one kind of medicine to treat patients, China should be in line with scientific law, that is, each claim that TCM treats any disease or indication should be supported by the data of evidence-based randomized clinical trials. As a priority, there is an urgent need to conduct more scientific experiments and clinical trials to verify the concepts and mechanisms of TCM. Also, China is encouraged to get rid of non-scientific concepts and theories of TCM. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center.

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