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Journal of Neurorestoratology 2020, 8(4): 217-231 https://doi.org/10.26599/JNR.2020.9040023
Special Report | Open Access | Issue | Published: 07 February 2021

Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China Version)

Show Author's Information Hongyun Huang1,( ),  Wenyong Gao1,  Zhenghui Yan2,  Aibing Liu3,  Xijing He4,  Ming Lu5,  Ying Liu3,  Yixin Shen6,  Jianhua Zhao7,  Zuncheng Zheng8,  Tiansheng Sun9,  Yaojian Rao10,  Yaojian Rao10
Beijing Hongtianji Neuroscience Academy, Beijing 100143, China
Shanghai Qikang Regenerative Medical Technologies Co., Ltd., Shanghai 200231, China
Institute of Neurorestoratology, Third Medical Center of General Hospital of PLA, Beijing 100039, China
Department of Orthopedics, Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an International Medical Center Hospital, Xi’an 710004, Shaanxi, China
Department of Neurosurgery, Second Affiliated Hospital of Hunan Normal University, Changsha 410003, Hunan, China
Department of Orthopedics, Second Affiliated Hospital of Soochow University, Suzhou 215004, Jiangsu, China
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
Department of Rehabilitation Medicine, Taian Central Hospital, Taian 271000, Shandong, China, 271000
Department of Orthopedics, Seventh Medical Center of General Hospital of PLA, Beijing 100700, China
Department of Orthopedics, Luoyang Bone Setting Hospital, Luoyang 471000, Henan, China
Keywords:
neurorestoration, standard, clinical-grade, olfactory ensheathing cell, cell culture, quality control
Cite this article:
Huang H, Gao W, Yan Z, et al. Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China Version). Journal of Neurorestoratology, 2020, 8(4): 217-231. https://doi.org/10.26599/JNR.2020.9040023
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Abstract Full text About this article

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.


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About this article

Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China Version)

Show Author's information Hongyun Huang1,( ), Wenyong Gao1, Zhenghui Yan2, Aibing Liu3, Xijing He4, Ming Lu5, Ying Liu3, Yixin Shen6, Jianhua Zhao7, Zuncheng Zheng8, Tiansheng Sun9, Yaojian Rao10, Yaojian Rao10
Beijing Hongtianji Neuroscience Academy, Beijing 100143, China
Shanghai Qikang Regenerative Medical Technologies Co., Ltd., Shanghai 200231, China
Institute of Neurorestoratology, Third Medical Center of General Hospital of PLA, Beijing 100039, China
Department of Orthopedics, Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an International Medical Center Hospital, Xi’an 710004, Shaanxi, China
Department of Neurosurgery, Second Affiliated Hospital of Hunan Normal University, Changsha 410003, Hunan, China
Department of Orthopedics, Second Affiliated Hospital of Soochow University, Suzhou 215004, Jiangsu, China
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
Department of Rehabilitation Medicine, Taian Central Hospital, Taian 271000, Shandong, China, 271000
Department of Orthopedics, Seventh Medical Center of General Hospital of PLA, Beijing 100700, China
Department of Orthopedics, Luoyang Bone Setting Hospital, Luoyang 471000, Henan, China

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.

Keywords: neurorestoration, standard, clinical-grade, olfactory ensheathing cell, cell culture, quality control

References(46)

[1]
F Féron, C Perry, J Cochrane, et al. Autologous olfactory ensheathing cell transplantation in human spinal cord injury. Brain. 2005, 128(Pt 12): 2951-2960.
DOI Google Scholar
[2]
YS Ren, GZ Tian, HM Wang, et al. Quality specification of human embryo olfactory ensheathing cells from olfactory bulb (in Chinese). J Clin Rehabil Tissue Eng Res. 2008, 16: 3156-3157.
Google Scholar
[3]
YS Ren, HY Huang, L Chen, et al. The primary culture for human embryonic olfactory ensheathing cells of olfactory bulb (in Chinese). Prog Anat Sci. 2010, 16(2): 97-100.
Google Scholar
[4]
P Tabakow, W Jarmundowicz, B Czapiga, et al. Transplantation of autologous olfactory ensheathing cells in complete human spinal cord injury. Cell Transplant. 2013, 22(9): 1591-1612.
DOI Google Scholar
[5]
J Xiao, L Chen, GS Mao, et al. Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells. J Neurorestoratology. 2017, 5: 175-179.
DOI Google Scholar
[6]
G Raisman. Specialized neuroglial arrangement may explain the capacity of vomeronasal axons to reinnervate central neurons. Neuroscience. 1985, 14(1): 237-254.
DOI Google Scholar
[7]
R Doucette. Glial influences on axonal growth in the primary olfactory system. Glia. 1990, 3(6): 433-449.
DOI Google Scholar
[8]
R Doucette. PNS-CNS transitional zone of the first cranial nerve. J Comp Neurol. 1991, 312(3): 451-466.
DOI Google Scholar
[9]
A Ramón-Cueto, M Nieto-Sampedro. Regeneration into the spinal cord of transected dorsal root axons is promoted by ensheathing glia transplants. Exp Neurol 1994, 127(2): 232-244.
DOI Google Scholar
[10]
A Ramón-Cueto, F Valverde. Olfactory bulb ensheathing glia: a unique cell type with axonal growth-promoting properties. Glia. 1995, 14(3): 163-173.
DOI Google Scholar
[11]
RJ Franklin, JM Gilson, IA Franceschini, et al. Schwann cell-like myelination following transplantation of an olfactory bulb-ensheathing cell line into areas of demyelination in the adult CNS. Glia. 1996, 17(3): 217-224.
DOI
[12]
Y Li, PM Field, G Raisman. Repair of adult rat corticospinal tract by transplants of olfactory ensheathing cells. Science. 1997, 277(5334): 2000-2002.
DOI Google Scholar
[13]
A Ramón-Cueto, J Avila. Olfactory ensheathing glia: properties and function. Brain Res Bull. 1998, 46(3): 175-187.
DOI Google Scholar
[14]
A Ramón-Cueto, GW Plant, J Avila, et al. Long-distance axonal regeneration in the transected adult rat spinal cord is promoted by olfactory ensheathing glia transplants. J Neurosci. 1998, 18(10): 3803-3815.
DOI Google Scholar
[15]
A Ramón-Cueto, MI Cordero, FF Santos-Benito, et al. Functional recovery of paraplegic rats and motor axon regeneration in their spinal cords by olfactory ensheathing glia. Neuron. 2000, 25(2): 425-435.
DOI Google Scholar
[16]
RJ Franklin. Remyelination by transplanted olfactory ensheathing cells. Anat Rec B New Anat. 2003, 271(1): 71-76.
DOI Google Scholar
[17]
G Raisman, Y Li. Repair of neural pathways by olfactory ensheathing cells. Nat Rev Neurosci. 2007, 8(4): 312-319.
DOI Google Scholar
[18]
EH Franssen, FM de Bree, J Verhaagen. Olfactory ensheathing glia: their contribution to primary olfactory nervous system regeneration and their regenerative potential following transplantation into the injured spinal cord. Brain Res Rev. 2007, 56(1): 236-258.
DOI Google Scholar
[19]
MW Richter, AJ Roskams. Olfactory ensheathing cell transplantation following spinal cord injury: hype or hope? Exp Neurol. 2008, 209(2): 353-367.
DOI Google Scholar
[20]
Z Su, C He. Olfactory ensheathing cells: biology in neural development and regeneration. Prog Neurobiol. 2010, 92(4): 517-532.
DOI Google Scholar
[21]
A Ramón-Cueto, C Muñoz-Quiles. Clinical application of adult olfactory bulb ensheathing glia for nervous system repair. Exp Neurol. 2011, 229(1): 181-194.
DOI Google Scholar
[22]
JR Higginson, SC Barnett. The culture of olfactory ensheathing cells (OECs)——a distinct glial cell type. Exp Neurol. 2011, 229(1): 2-9.
DOI Google Scholar
[23]
Y Li, L Chen, YX Zhao, et al. Intracranial transplant of olfactory ensheathing cells can protect both upper and lower motor neurons in amyotrophic lateral sclerosis. Cell Transplant. 2013, 22(1): S51-S65.
DOI Google Scholar
[24]
WJ Wu, GZ Hui, H Lu, et al. Effects of different materials and culture methods on the purity of fetal olfactory ensheathing cells (in Chinese). Chin J Exp Surg. 2004, 21(7): 841-844.
Google Scholar
[25]
LM Qian, ZJ Zhang, P Jiang. A novel glia: olfactory ensheathing cell (in Chinese). Prog Anat Sci. 2006, 12(1): 63-66.
Google Scholar
[26]
HY Huang. Basic and clinical study of olfactory ensheathing cell transplantation for spinal cord injury (in Chinese). Chin J Clin Rehabil. 2002, 6(14): 2027-2029.
Google Scholar
[27]
HY Huang, HM Wang, B Xiu, et al. Preliminary report of clinical trial for olfactory ensheathing cell transplantation treating the spinal cord injury (in Chinese). J Navy Gen Hosp PLA. 2002 (1): 18-21.
Google Scholar
[28]
HY Huang, L Chen, HM Wang, et al. Influence of patients’ age on functional recovery after transplantation of olfactory ensheathing cells into injured spinal cord injury. Chin Med J (Engl). 2003, 116(10): 1488-1491.
Google Scholar
[29]
HY Huang, L Chen, HT Xi, et al. Fetal olfactory ensheathing cells transplantation in amyotrophic lateral sclerosis patients: a controlled pilot study. Clin Transplant. 2008, 22(6): 710-718.
DOI Google Scholar
[30]
A Mackay-Sim, F Féron, J Cochrane, et al. Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial. Brain. 2008, 131(Pt 9): 2376-2386.
DOI Google Scholar
[31]
HY Huang, L Chen, HT Xi, et al. Olfactory ensheathing cells transplantation for central nervous system diseases in 1,255 patients (in Chinese). Chin J Repar Reconstruct Surg. 2009, 23(1): 14-20.
Google Scholar
[32]
L Chen, HY Huang, HT Xi, et al. Intracranial transplant of olfactory ensheathing cells in children and adolescents with cerebral palsy: a randomized controlled clinical trial. Cell Transplant. 2010, 19(2): 185-191.
DOI Google Scholar
[33]
HY Huang, HT Xi, L Chen, et al. Long-term outcome of olfactory ensheathing cell therapy for patients with complete chronic spinal cord injury. Cell Transplant. 2012, 21(Suppl 1): S23-S31
DOI Google Scholar
[34]
L Chen, D Chen, H Xi, et al. Olfactory ensheathing cell neurorestorotherapy for amyotrophic lateral sclerosis patients: benefits from multiple transplantations. Cell Transplant. 2012, 21(Suppl): S65-S77.
DOI Google Scholar
[35]
YJ Rao, WX Zhu, YX Guo, et al. Long-term outcome of olfactory ensheathing cell transplantation in six patients with chronic complete spinal cord injury. Cell Transplant. 2013, 22(Suppl 1): S21-S25.
DOI Google Scholar
[36]
P Tabakow, G Raisman, W Fortuna, et al. Functional regeneration of supraspinal connections in a patient with transected spinal cord following transplantation of bulbar olfactory ensheathing cells with peripheral nerve bridging. Cell Transplant. 2014, 23(12): 1631-1655.
DOI Google Scholar
[37]
L Chen, HT Xi, HY Huang, et al. Multiple cell transplantation based on an intraparenchymal approach for patients with chronic phase stroke. Cell Transplant. 2013, 22(Suppl 1): S83-S91.
DOI Google Scholar
[38]
HT Xi, L Chen, HY Huang, et al. Preliminary report of multiple cell therapy for patients with multiple system atrophy. Cell Transplant. 2013, 22(Suppl 1): S93-S99.
DOI Google Scholar
[39]
L Chen, HY Huang, HT Xi, et al. A prospective randomized double-blind clinical trial using a combination of olfactory ensheathing cells and Schwann cells for the treatment of chronic complete spinal cord injuries. Cell Transplant. 2014, 23(Suppl 1): S35-S44.
DOI Google Scholar
[40]
S Wang, JK Lu, YA Li, et al. Autologous olfactory lamina propria transplantation for chronic spinal cord injury: 3-year follow-up outcomes from a prospective double-blinded clinical trial. Cell Transplant. 2016, 25(1): 141-157.
DOI Google Scholar
[41]
XL Guo, X Wang, Y Li, et al. Olfactory ensheathing cell transplantation improving cerebral infarction sequela: a case report and literature review. J Neurorestoratology. 2019, 7(2): 82-88.
DOI Google Scholar
[42]
YL Wang, XL Guo, J Liu, et al. Olfactory ensheathing cells in chronic ischemic stroke: A phase 2 double-blind, randomized, controlled trial. J Neurorestoratology. 2020, 8(3): 182-193.
DOI Google Scholar
[43]
HY Huang, WY Gao, J Xiao. Preparation Method for Olfactory Ensheathing Cells. US patent, No. US 10828734(B2), Nov 20, 2020.
[44]
HY Huang, W Young, L Chen, et al. Clinical cell therapy guidelines for neurorestoration (IANR/CANR 2017). Cell Transplant. 2018, 27(2): 310-324.
Google Scholar
[45]
GT Gobbel, D Kondziolka, W Fellows-Mayle, et al. Cellular transplantation for the nervous system: impact of time after preparation on cell viability and survival. J Neurosurg. 2010, 113(3): 666-672.
DOI Google Scholar
[46]
XR Jiang, J Xiao, YS Ren, et al. The influence of 4 degree centigrade concervation on cells activity of rats’ olfactory bulbs derived olfactory ensheathing cells (in Chinese). Prog Anat Sci. 2011, 17(5), 17: 424-427.
Google Scholar
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Received: 23 October 2020
Revised: 05 October 2020
Accepted: 28 December 2020
Published: 07 February 2021
Issue date: December 2020

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© The authors 2020

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This article is published with open access at http://jnr.tsinghuajournals.com

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