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Journal of Neurorestoratology  2020, Vol. 8 Issue (4): 217-231    doi: 10.26599/JNR.2020.9040023
Special Report     
Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China Version)
Hongyun Huang1,(✉)(),Wenyong Gao1,Zhenghui Yan2,Aibing Liu3,Xijing He4,Ming Lu5,Ying Liu3,Yixin Shen6,Jianhua Zhao7,Zuncheng Zheng8,Tiansheng Sun9,Yaojian Rao10,On behalf of Chinese Association of Neurorestoratology (Preparatory) and China Committee of International Association of Neurorestoratology
1 Beijing Hongtianji Neuroscience Academy, Beijing 100143, China
2 Shanghai Qikang Regenerative Medical Technologies Co., Ltd., Shanghai 200231, China
3 Institute of Neurorestoratology, Third Medical Center of General Hospital of PLA, Beijing 100039, China
4 Department of Orthopedics, Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an International Medical Center Hospital, Xi’an 710004, Shaanxi, China
5 Department of Neurosurgery, Second Affiliated Hospital of Hunan Normal University, Changsha 410003, Hunan, China
6 Department of Orthopedics, Second Affiliated Hospital of Soochow University, Suzhou 215004, Jiangsu, China
7 Department of Neurology, First Affiliated Hospital of Xinxiang Medical University, Henan Key Laboratory of Neurorestoratology, Henan Joint International Research Laboratory of Neurorestoratology for Senile Dementia, Xinxiang 453100, Henan, China
8 Department of Rehabilitation Medicine, Taian Central Hospital, Taian 271000, Shandong, China, 271000
9 Department of Orthopedics, Seventh Medical Center of General Hospital of PLA, Beijing 100700, China
10 Department of Orthopedics, Luoyang Bone Setting Hospital, Luoyang 471000, Henan, China
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Abstract  

Currently, there are many different standards for the quality control of olfactory ensheathing cell (OEC) culture prepared from human olfactory bulb and mucosa. It is challenging to compare the clinical results of OEC treatment from different hospitals. Based on various standards, the Chinese Association of Neurorestoratology (CANR; Preparatory) and China Committee of International Association of Neurorestoratology (IANR-China Committee) organized professional experts in this field to evaluate the data and develop a standard for clinical applications, including donor evaluation, sample collection, cell culture, cell testing, packaging labels, storage, transportation, and quality control of intermediate/finished cell products, as well as training and management procedures for laboratory operators, the use and management of materials and equipment, and routine maintenance of a clean environment. These standards apply to the quality and control of OEC culture using human olfactory bulb and mucosa as the sample source for the member units of the CANR (Preparatory) and IANR-China Committee. It serves as a reference for physicians around the world who perform OEC clinical applications. This standard represents the minimum required standards for quality control when performing clinical-grade OEC cultures in clinical neurorestorative treatments.



Key wordsstandard      clinical-grade      olfactory ensheathing cell      cell culture      quality control      neurorestoration     
Received: 23 October 2020      Published: 07 February 2021
Corresponding Authors: Hongyun Huang     E-mail: huanghongyun001@126.com;hongyunh@gmail.com
Cite this article:

Hongyun Huang, Wenyong Gao, Zhenghui Yan, Aibing Liu, Xijing He, Ming Lu, Ying Liu, Yixin Shen, Jianhua Zhao, Zuncheng Zheng, Tiansheng Sun, Yaojian Rao. Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China Version). Journal of Neurorestoratology, 2020, 8: 217-231.

URL:

http://jnr.tsinghuajournals.com/10.26599/JNR.2020.9040023     OR     http://jnr.tsinghuajournals.com/Y2020/V8/I4/217

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