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. 2018 Feb;27(2):310-324.
doi: 10.1177/0963689717746999.

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

Hongyun Huang  1 , Wise Young  2 , Lin Chen  3 , Shiqing Feng  4 , Ziad M Al Zoubi  5 , Hari Shanker Sharma  6 , Hooshang Saberi  7 , Gustavo A Moviglia  8 , Xijing He  9 , Dafin F Muresanu  10 , Alok Sharma  11 , Ali Otom  12 , Russell J Andrews  13 , Adeeb Al-Zoubi  14 , Andrey S Bryukhovetskiy  15 , Elena R Chernykh  16 , Krystyna Domańska-Janik  17 , Emad Jafar  5 , W Eustace Johnson  18 , Ying Li  19 , Daqing Li  19 , Zuo Luan  20 , Gengsheng Mao  1 , Ashok K Shetty  21 , Dario Siniscalco  22 , Stephen Skaper  23 , Tiansheng Sun  24 , Yunliang Wang  25 , Lars Wiklund  26 , Qun Xue  27 , Si-Wei You  28 , Zuncheng Zheng  29 , Milan R Dimitrijevic  30 , W S El Masri  31 , Paul R Sanberg  32 , Qunyuan Xu  33 , Guoming Luan  34 , Michael Chopp  35 , Kyoung-Suok Cho  36 , Xin-Fu Zhou  37 , Ping Wu  38 , Kai Liu  39 , Hamid Mobasheri  40 , Seiji Ohtori  41 , Hiroyuki Tanaka  42 , Fabin Han  43 , Yaping Feng  44 , Shaocheng Zhang  45 , Yingjie Lu  46 , Zhicheng Zhang  24 , Yaojian Rao  47 , Zhouping Tang  48 , Haitao Xi  49 , Liang Wu  50 , Shunji Shen  51 , Mengzhou Xue  52 , Guanghong Xiang  53 , Xiaoling Guo  54 , Xiaofeng Yang  55 , Yujun Hao  56 , Yong Hu  57 , Jinfeng Li  26 , Qiang Ao  58 , Bin Wang  59 , Zhiwen Zhang  60 , Ming Lu  61 , Tong Li  62
Affiliations

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

Hongyun Huang et al. Cell Transplant. 2018 Feb.

Abstract

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version "Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)". The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility.

Keywords: cell therapy; clinical application guideline neurorestoratology; neurorestoration.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Paul R. Sanberg is Co-Editor-in-Chief of Cell Transplantation. Neither Paul R. Sanberg nor any of his colleagues were involved in the peer review or decision making processes for this manuscript.

Figures

Fig. 1.
Fig. 1.
Recommended standards for personnel and institutions. The standards mainly contain 3 parts: equipment, personal and institutional review board, and ethics committee approval.
Fig. 2.
Fig. 2.
Provisions for cell therapy.
Fig. 3.
Fig. 3.
Provision for cell type nomenclature. The nomenclature and description of the cells used for therapy should specify species, developmental stage, tissue of origin, method to isolate or expand the cells, and selection process. If mixtures of cells are used, the type of cells should be specified.
Fig. 4.
Fig. 4.
Cell quality control. Quality control is essential for ensuring safety and efficacy of cell therapies from the preparation of cells to cell transplantation. Sterility of the cell preparation must be rigorously monitored.
See this image and copyright information in PMC

References

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    1. Chinese Branch of the International Association of Neurorestoratology and Preparatory Committee of Chinese Association of Neurorestoratology. Standard recommendation for the application of Chinese clinical cell therapy for neurorestoration. Cell Transplant. 2013;22(Suppl 1):S5–S10. - PubMed
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