Comparison of Research and Clinical Transformation on Mesenchymal Stem Cells between China and the US

doi:10.13523/j.cb.1909020

China Biotechnology

2020, Vol. 40

Issue (4): 97-107 DOI: 10.13523/j.cb.1909020

Comparison of Research and Clinical Transformation on Mesenchymal Stem Cells between China and the US

YUAN Ya-kun^1,²,LIU Guang-yang^3,⁴,LIU Yong-jun^3,⁴,XIE Ya-fang^3,⁴,WU Hao^1,^2,^*(

)

1 National Science Library, Chinese Academy of Sciences, Beijing 100190, China
2 School of Economics and Management, University of Chinese Academy of Sciences, Beijing 100190, China
3 Stem Cell Biology and Regenerative Medicine Institution, Yi-Chuang Institute of Bio- Industry, Beijing 100176, China
4 Beijing Believe China Biotech Co., Ltd. Beijing 100176, China

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Abstract

Objective: Compare the development status and trends of mesenchymal stem cells (MSCs) in basic research, patent application and clinical trial registration between China and the US. Find out the main characteristics of MSCs research in these two countries and provide suggestions for Chinese MSCs development. Methods: The paper data in SCI database, the patent data in DII database and the clinical trial data in Clinical Trials database are retrieved. The quantitative analysis is carried out by Excel and DDA. SWOT analysis is used to discuss the advantages and disadvantages, opportunities and threats of Chinese MSCs development. Results: Although China started late on MSCs research, it has developed rapidly in recent years. The number of papers since 2014 and patent applications in 2016 exceeds that of the United States, and the number of clinical trials has reached more than 200. China has advantages in the research fields of osteoporosis and spinal cord injury and some clinical trials such as endocrine system diseases and autoimmune diseases. However, there is still room for improvement in the study of MSCs in China. Conclusion: China should give full play to its existing advantages and strengthen the strategic layout; attach importance to the enterprise-led new drug development path; make efforts to enhance its international competitiveness and influence; increase capital investment and support of industrial policies and improve the regulatory mechanism and evaluation system.

Key words： Mesenchymal stem cells Regenerative medicine Clinical trial

Received: 10 September 2019 Published: 18 May 2020

ZTFLH:

Q819

Corresponding Authors: Hao WU E-mail: wuh@mail.las.ac.cn

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	Ya-kun YUAN
	Guang-yang LIU
	Yong-jun LIU
	Ya-fang XIE
	Hao WU

Cite this article:

YUAN Ya-kun,LIU Guang-yang,LIU Yong-jun,XIE Ya-fang,WU Hao. Comparison of Research and Clinical Transformation on Mesenchymal Stem Cells between China and the US. China Biotechnology, 2020, 40(4): 97-107.

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https://manu60.magtech.com.cn/biotech/10.13523/j.cb.1909020 OR https://manu60.magtech.com.cn/biotech/Y2020/V40/I4/97

Fig.1 Biological characteristics of MSCs

Fig.2 The trend in the number of papers

Fig.3 The trend in the number of papers in China and the US in the past decade

Table 1 The top 10 organizations in China and the US in the past decade

Fig.4 Key words of papers in China and the US in the past decade

Fig.5 The trend in the number of patent applications

Fig.6 The trend in the number of patent applications in China and the US

Table 2 The technical fields distribution of patent in China and the US

Fig.7 The trend in the number of clinical trials in China and the US

Fig.8 The phases distribution of clinical trials in China and the US

Table 3 The main organizations of clinical trials in China and the US

Table 4 The status distribution of clinical trials in China and the US

Table 5 Differences between China and the US on new drug supervision

Table 6 Catalogue of new drug acceptance in China(2018~2019.8)


[1]	毛开云, 范月蕾, 王跃 , 等. 间充质干细胞治疗产品开发现状与趋势. 中国生物工程杂志, 2017,37(10):126-134.

[1]	Mao K Y, Fan Y L, Wang Y , et al. Development status and trend analysis of mesenchymal stem cells therapeutic products. China Biotechnology, 2017,37(10):126-134.

[2]	Pittenger M F, Mackay A M, Beck S C , et al. Multilineage potential of adult human mesenchymal stem cells. Science, 1999,284(5411):143-147.

[3]	李明, 詹成, 代曦煜 , 等. 间充质干细胞临床应用的研究进展. 复旦学报(医学版), 2016,43(4):469-474.

[3]	Li M, Zhan C, Dai X Y , et al. Advances on mesenchymal stem cells in clinical application. Fudan University Journal of Medical Sciences, 2016,43(4):469-474.

[4]	Le Blanc K, Tammik C, Rosendahl K , et al. HLA expression and immunologic properties of differentiated and undifferentiated mesenchymal stem cells. Exp Hematol, 2003,31(10):890-896.

[5]	Zhang Z, Fu J, Xu X , et al. Safety and immunological responses to human mesenchymal stem cell therapy indifficult-to-treat HIV-1-infected patients. AIDS, 2013,27(8):1283-1293.

[6]	Le Blanc K, Frassoni F, Ball L , et al. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet, 2008,371(9624):1579-1586.

[7]	Wang L, Cong X, Liu G , et al. Human umbilical cord mesenchymal stem cell therapy for patients with activerheumatoid arthritis: safety and efficacy. Stem Cells Dev, 2013,22(24):3192-3202.

[8]	Caplan A I . Mesenchymal stem-cells. Journal of Orthopaedic Research, 1991,9(5):641-650.

[9]	Osiris . About Osiris. [2019-07-01]. http://www.osiris.com/about-3/.

[10]	广州赛莱拉干细胞科技股份有限公司. 关于我们. [2019-07-01]. http://www.saliai.com/about/company.

[10]	SALIAI. About us. [2019-07-01]. http://www.saliai.com/about/company.

[11]	毛开云 . 国外干细胞研发企业及其相关产品. [2019-07-17]. https://wenku.baidu.com/view/1ec157ffba0d4a7302763a33.html.

[11]	Mao K Y . Foreign stem cell research and development companies and related products. [2019-07-17]. https://wenku.baidu.com/view/1ec157ffba0d4a7302763a33.html.

[12]	李丹 . 美国罕见病药物研发激励政策概述及对我国的启示. 中国药物警戒, 2018,15(6):339-342.

[12]	Li D . Overview of incentives for rare disease drugs research and development in the United States and enlightenment for China. Chinese Journal of Pharmacovigilance, 2018,15(6):339-342.

[13]	赵志刚, 白彩珍 . Ⅰ类新药——中美创新对比. 药品评价, 2010,7(4):2-6.

[13]	Zhao Z G, Bai C Z . Class Ⅰ of new drugs-Comparison of new drug development between China and the United States. Drug Evaluation, 2010,7(4):2-6.

[14]	朱斌, 赵志刚 . 从创新药物申报角度探讨中美新药评审制度的异同. 药学进展, 2015,39(11):827-831.

[14]	Zhu B, Zhao Z G . Discussion on the similarities and di? erences between drug review systems in China and the USA from the view of innovative drug application. Progress in Pharmaceutical Sciences, 2015,39(11):827-831.

[15]	陈云, 邹宜諠, 邵蓉, 周斌 . 美国干细胞产业发展政策与监管及对我国的启示. 中国医药工业杂志, 2018,49(12):1733-1741.

[15]	Chen Y, Zou Y X, Shao R , et al. The research and enlightenment about development policy and regulation of American stem sell industry. Chinese Journal of Pharmaceuticals, 2018,49(12):1733-1741.

[16]	陈云, 邹宜諠, 张晓慧, 周斌 . 韩国与日本干细胞药品审批、监管及对我国的启示. 中国新药杂志, 2018,27(3):267-272.

[16]	Chen Y, Zou Y X, Zhang X H , et al. The approval and supervision of stem cell drugs in South Korea and Japan and their implications for China. Chinese Journal of New Drugs, 2018,27(3):267-272.

[17]	科技日报. 启动临床项目:我国干细胞研究跻身世界前列. [2019-08-02]. http://digitalpaper.stdaily.com/http_www.kjrb.com/kjrb/html/2017-04/17/content_367406.htm? div=-1.

[17]	Science and Technology Daily. Start clinical projects: China's stem cell research ranks among the top in the world. [2019-08-02]. http://digitalpaper.stdaily.com/http_www.kjrb.com/kjrb/html/2017-04/17/content_367406.htm? div=-1.

[18]	财新网. 卫计委酝酿出台政策助推干细胞研发. [2019-08-02]. http://china.caixin.com/2014-12-22/100766485.html.

[18]	Caixin.com. National Health Commission is preparing policies to promote stem cell research and development. [2019-08-02]. http://china.caixin.com/2014-12-22/100766485.html.

[19]	Polaris Market Research. Global Mesenchymal Stem Cells Market - Industry Report, 2018-2026.[2019-07-10]. https://www.polarismarketresearch.com/industry-analysis/mesenchymal-stem-cells-market.

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