Regenerative Medicine in China: Demands, Capacity, and Regulation Biao Cheng1,2, Shuliang Lu3 and Xiaobing Fu1,4*
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Cheng et al. Burns & Trauma (2016) 4:24 DOI 10.1186/s41038-016-0046-8 REVIEW Open Access Regenerative medicine in China: demands, capacity, and regulation Biao Cheng1,2, Shuliang Lu3 and Xiaobing Fu1,4* Abstract Regenerative medicine (RM) is an emerging interdisciplinary field of research. Its clinical application focuses on the repair, replacement, and regeneration of cells, tissues, and organs by approaches including cell reprogramming, stem cell transplantation, tissue engineering, activating factors, and clone treatment. RM has become a hot point of research in China and other countries. China’s main and local governments have attached great importance to RM and given strong support in relevant policies and funding. About 3.5 billion RMB has been invested in this field. Since 1999, China has established about 30 RM centers and cooperates with many advanced countries in RM research and benefits from their cooperation. However, China needs to develop standards, regulations, and management practices suitable for the healthy development of RM. In this review, we focus on its great demand, capacity, and relative regulations. Keywords: Regenerative medicine, Stem cell, Tissue engineering, China Background In the past 20 years, the RM market has continued Annually, about 100 million Chinese patients will receive to grow in China and other countries such as the treatment by tissue repair and regeneration technologies USA, Europe, Japan, and Singapore. As the largest because of the sharp increase in various injuries, acci- developing country, China has impressed the world dents, and diseases of aging. However, the current para- with its findings in stem cells, tissue engineering, digm of “healing by scar tissue replacement,” regardless of active molecules, and gene therapy as well as its na- superficial tissues or visceral organs, is stagnating and is tional strategies and regulation of RM. These achieve- far away from the ultimate goal of “regenerating the im- ments may benefit China in both disease treatment paired organ.” Regenerative medicine (RM) is gradually and society development [3]. being used to restore the intrinsic repair ability with stem cell transplantation, tissue engineering, activating factors, cell reprogramming, and genetic treatments. RM holds Review sound promise of restoring organ function that is im- Strategies, guidance, funding, and industrialization of RM paired because of congenital disorders, acquired disease, in china trauma, and aging by replacing or regenerating cells, tis- National strategies sues, and even organs. RM is expected to transcend trad- The central government of China supports the develop- itional organ transplantation and replacement. Stem cell ment of RM. In the 2006 National Plan for Long- and technology and tissue engineering have an outstanding Medium-Term Scientific and Technological Development – role in RM. RM will become one of the most promising (2006 2020), stem cells and RM technologies were the im- areas of life science in the twenty-first century [1, 2]. portant fields among the five biotechnologies (http:// www.gov.cn/gzdt/2009-08/21/content_1398305.htm). Also, local governments have adopted stem cell research as one * Correspondence: [email protected] 1College of Life Sciences, Medical College of PLA, General Hospital of PLA, of the priorities of technological development and provided Beijing 100853, People’s Republic of China active support. Relevant government departments and aca- 4 Chinese Academy of Engineering (Division of Medical and Health), College demia have paid close attention to and encouraged the de- of Life Sciences, Medical College of PLA, General Hospital of PLA, 28 Fu Xian Road, Beijing 100853, People’s Republic of China velopment of RM. In the Science & Technology on Public Full list of author information is available at the end of the article Health in China: A Roadmap to 2050, issued by the © 2016 The Author(s) Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Cheng et al. Burns & Trauma (2016) 4:24 Page 2 of 7 Table 1 Management specification of stem cell transplantation and “Construction of Research Centers for Basic and techniques Forefront Scientific Research.” Academia held three Time Management specification of stem cell transplantation techniques Xiangshan Science Conferences on RM, in 2005, 2010, 2006 Unrelated Hematopoietic Stem Cell Transplantation Technique and 2015, to discuss the philosophy, scope, and major Unrelated Hematopoietic Stem Cell Transplantation Collection breakthroughs needed for the development of RM in Technique China and the key scientific issues to be addressed. In 2009 Cord Blood Stem Cell Therapy Technology (Trial) addition, the Xiangshan Science Conference organized Tissue-engineering Tissue Transplantation Therapy Technique (Trial) seminars on stem cell biology and cloning, strategies for research and development of gene therapy and biomate- rials, and tissue engineering. Chinese Academy of Sciences (CAS) [4], and the Study on the Long- and Medium-Term Development Strategy for Regulatory and scientific guidance China Engineering Science and Technology, issued by the Policies and regulations reflect that China is gradually Chinese Academy of Engineering (CAE) (http://news. strengthening the management of RM research and clinical sciencenet.cn/htmlnews/2012/12/273300-3.shtm), RM was application. Since 1999, when the Ministry of Health (MH) considered a major research field. In the Roadmap of promulgated the first Umbilical cord blood stem cell bank Translational Medicine in China issued by CAE, RM and management approach (Trial), about 30 rules and regulations biotherapy are main fields. Industrialization of RM is a part have been issued by the Ministry of Science and Technology of the “12th Five-Year Planning” and will be nurtured as a (MST), the MH, and the State Food and Drug Agency source of economic growth. (SFDA) (Table 1). The strategic science and technology projects from In 2011, the First National Stem Cell Research Guidance CAS can be divided into “Forward-Looking Strategic and Coordination Committee was established for the Priority Research Program of Science and Technology” overall design and scientific planning of stem cell research Fig. 1 National Natural Science Foundation of China investment in regenerative medicine from 2000 to 2014. a Amount of funding. b Number of funds Cheng et al. Burns & Trauma (2016) 4:24 Page 3 of 7 in China. In December 2011, the Notice on Carrying out Funding support and resources Self-inspection and Self-rectification Campaign Regarding Multiple sources are funding RM studies and transla- Stem Cell Clinical Research and Application was issued. tional application. After 1999, the MST approved the In 2013, the stem cell clinical research and application National Program on Key Basic Research Project (973 rectification lead group of the MH and SFDA formu- Program) related to tissue engineering, and the stem lated the regulations Management Specification of cell field had the largest number of “973 Program” Stem Cell Clinical Trials (Trial), Management Specifi- projects. Research into the clinical transformation and cation of Stem Cell Clinical Trial Research Base application of stem cell therapy was established in the (Trial),andStem Cell Preparation Quality Control biotechnology and medical technology field of the and Pre-clinical Research Guidelines (Trial).These “863 Program.” The National Natural Science Founda- regulations will be implemented soon and help in the tion (NNSF) funded about 200 million RMB for this development of RM in China. In 2015, China MH study, including 5627 items (Fig. 1a, b). Up to now, opens the window to allow the stem cell clinic trial about 3 billion RMB from the MST, CAS, and NNSF and stem cell research bases which will promote the has been invested in this field. Both the amount of development of stem cell research and translational funding and number of projects are increasing annu- application in China. ally. Other funding for RM from companies is about Fig. 2 Outputs of regenerative medicine research papers compared with major countries (ISI Web of Knowledge). a Stem cells. b Tissue engineering Cheng et al. Burns & Trauma (2016) 4:24 Page 4 of 7 Table 2 Main monographs on regenerative medicine published in China Time Name Author Publishing company 2008.03 Regenerative Medicine: From Basic to Clinic Fu Xiaobing, Wang Zhengguo, Shanghai Scientific and Technical Publishers Research Wu Zuze [5] 2010.05 Regenerative Medicine: Theory and Technology Pei Xuetao [6] Science Press 2012.03 Regenerative Medicine Ding Fei, Liu Wei, Gu Xiaosong [7] People’s Medical Publishing House 2013.08 Regenerative Medicine: Basic and Clinical Research Fu Xiaobing, Wang Zhengguo, People’s Medical Publishing House Wu Zuze [8] 2014.10 Tissue Engineering and Regenerative Medicine Jin yan [9] People’s Medical Publishing House 2015.03 Chinese Discipline Development Strategy Chinese Academy of Sciences [10] Science Press Regenerative