Stem cell therapies and regenerative medicine in China

Huang, Sha; Fu, Xiaobing

doi:10.1007/s11427-014-4608-3

Cited by 17 publications

(11 citation statements)

References 36 publications

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“…Recently, in China, drafts of a stem cell-specific clinical therapy quality control standard and management of stem cell-based clinical experiments were implemented by the China Food and Drug Administration (CFDA) (http://www.sda.gov.cn) and National Health and Family Planning Commission of the People’s Republic of China (NHFPC) (http://www.nhfpc.gov.cn/). Each of these guidelines focuses on the efficacy, safety, and pharmaceutical quality, which are influenced by the cell sources, manufacturing systems, and specific therapeutic protocols (George, 2011, Huang and Fu, 2014). In addition to validating the biosafety of the hESCs, the CFDA and FDA both require rigorous testing of the donors' eligibility, thus differentiating these guidelines from the present NIH guidelines on human stem cell research (George, 2011, Huang and Fu, 2014, Jonlin, 2014).…”

Section: Introductionmentioning

confidence: 99%

Accreditation of Biosafe Clinical-Grade Human Embryonic Stem Cells According to Chinese Regulations

Wang

et al. 2017

Stem Cell Reports

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SummaryHuman embryonic stem cells (hESCs) are promising in regenerative medicine. Although several hESC-based clinical trials are under way, a widely accepted standard of clinical-grade cells remains obscure. To attain a completely xeno-free clinical-grade cell line, the system must be free of xenogenic components, the cells must have a comprehensive set of functions, and good manufacturing practice conditions must be used. In this study, following these criteria, we successfully derived two hESC lines, which were thereby considered “clinical-grade embryonic stem cells”. In addition to the primary capacity for pluripotency, these two cell lines were efficiently differentiated into various types of clinical-grade progeny. Importantly, the cells were recognized by the National Institutes for Food and Drug Control of China for further eligible accreditation. These data indicate that we have established completely xeno-free clinical-grade hESC lines and their derivatives, which will be valuable for the foundation of an international standard for clinical-grade cells for therapy.

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Section: Introductionmentioning

confidence: 99%

Accreditation of Biosafe Clinical-Grade Human Embryonic Stem Cells According to Chinese Regulations

Wang

et al. 2017

Stem Cell Reports

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“…Recent progress and remarkable advancement in stem cell research has led to an exciting prospect of regenerative medicine and provided new strategies to treat neurodegenerative disease (Huang and Fu, 2014). Human embryonic stem cell (ESC)-derived NSCs transplanted into the Parkinson's rodent model have been reported to successfully gen-erate DA neurons in the host and ameliorate the disease (Ben-Hur et al, 2004;Kim et al, 2002;Redmond et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

Treatment of multiple sclerosis by transplantation of neural stem cells derived from induced pluripotent stem cells

Zhang

Cao

et al. 2016

Sci. China Life Sci.

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Multiple sclerosis (MS) is an autoimmune disease of the central nervous system (CNS), with focal T lymphocytic infiltration and damage of myelin and axons. The underlying mechanism of pathogenesis remains unclear and there are currently no effective treatments. The development of neural stem cell (NSC) transplantation provides a promising strategy to treat neurodegenerative disease. However, the limited availability of NSCs prevents their application in neural disease therapy. In this study, we generated NSCs from induced pluripotent stem cells (iPSCs) and transplanted these cells into mice with experimental autoimmune encephalomyelitis (EAE), a model of MS. The results showed that transplantation of iPSC-derived NSCs dramatically reduced T cell infiltration and ameliorated white matter damage in the treated EAE mice. Correspondingly, the disease symptom score was greatly decreased, and motor ability was dramatically rescued in the iPSC-NSC-treated EAE mice, indicating the effectiveness of using iPSC-NSCs to treat MS. Our study provides pre-clinical evidence to support the feasibility of treating MS by transplantation of iPSC-derived NSCs.induced pluripotent stem cell, multiple sclerosis, neural stem cell, regenerative medicine, transplantation Citation:Zhang, C., Cao, J., Li, X., Xu, H., Wang, W., Wang, L., Zhao, X., Li, W., Jiao, J., Hu, B., Zhou, Q., and Zhao, T. (2016). Treatment of multiple sclerosis by transplantation of neural stem cells derived from induced pluripotent stem cells. Sci China Life Sci 59, 950 -957.

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“…Uncontrollable variations such as age and genetic background influence the interpretation of different experimental settings. Recent progress in FXS human embryonic stem (ES) cells and iPS cells has overcome the drawbacks of the mouse models, which offers us a great tool to understand the pathogenic mechanisms in absence of FMRP (Eiges et al, 2007;Huang and Fu, 2014;Sheridan et al, 2011;Telias et al, 2013;Wu et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

Integrated transcriptome analysis of human iPS cells derived from a fragile X syndrome patient during neuronal differentiation

Lü

Chen

Feng

et al. 2016

Sci. China Life Sci.

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Fragile X syndrome (FXS) patients carry the expansion of over 200 CGG repeats at the promoter of fragile X mental retardation 1 (FMR1), leading to decreased or absent expression of its encoded fragile X mental retardation protein (FMRP). However, the global transcriptional alteration by FMRP deficiency has not been well characterized at single nucleotide resolution, i.e., RNA-seq. Here, we performed in-vitro neuronal differentiation of human induced pluripotent stem (iPS) cells that were derived from fibroblasts of a FXS patient (FXS-iPSC). We then performed RNA-seq and examined the transcriptional misregulation at each intermediate stage during in-vitro differentiation of FXS-iPSC into neurons. After thoroughly analyzing the transcriptomic data and integrating them with those from other platforms, we found up-regulation of many genes encoding TFs for neuronal differentiation (WNT1, BMP4, POU3F4, TFAP2C, and PAX3), down-regulation of potassium channels (KCNA1, KCNC3, KCNG2, KCNIP4, KCNJ3, KCNK9, and KCNT1) and altered temporal regulation of SHANK1 and NNAT in FXS-iPSC derived neurons, indicating impaired neuronal differentiation and function in FXS patients. In conclusion, we demonstrated that the FMRP deficiency in FXS patients has significant impact on the gene expression patterns during development, which will help to discover potential targeting candidates for the cure of FXS symptoms.

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Stem cell therapies and regenerative medicine in China

Cited by 17 publications

References 36 publications

Accreditation of Biosafe Clinical-Grade Human Embryonic Stem Cells According to Chinese Regulations

Accreditation of Biosafe Clinical-Grade Human Embryonic Stem Cells According to Chinese Regulations

Treatment of multiple sclerosis by transplantation of neural stem cells derived from induced pluripotent stem cells

Integrated transcriptome analysis of human iPS cells derived from a fragile X syndrome patient during neuronal differentiation

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