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Expert Opinion | Open Access

Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells

Juan Xiao1,2, Lin Chen3, Gengsheng Mao1, Wenyong Gao1,2, Ming Lu4, Xijing He5, Hongyun Huang1,2( )
Institute of Neurorestoratology, The General Hospital of Chinese People’s Armed Police Forces, Beijing, People’s Republic of China
Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, People’s Republic of China
Department of Neurosurgery, Tsinghua University Yuquan Hospital, Beijing, People’s Republic of China
Department of Neurosurgery, 163 Hospital of PLA (Second Affiliated Hospital of Hunan Normal University), Changsha, Hunan Province, People’s Republic of China
Department of Orthopedics, Second Affiliated Hospital of Xi’an Jiaotong University, Xian, Shanxi Provine, People’s Republic of China
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Abstract

Olfactory ensheathing cells (OECs) are a novel type of glial cell that can perform and promote many neurorestorative processes in vivo after transplant. To date, dozens of preclinical and clinical studies have confirmed that OECs have unique restoring effects in animal models and human subjects with neurological degeneration or damage, such as spinal cord injury, stroke, cerebral palsy, traumatic brain injury, and motor neuron disease (amyotrophic lateral sclerosis). To ensure the safety and effectiveness of clinical applications utilizing this type of cell, it is important to standardize cell-culture and quality-control processes. Based on a comprehensive review of published clinical studies, as well as existing methods of OEC culture and quality control currently utilized by hospitals and biomedical enterprises, the Chinese Association of Neurorestoratology has developed a set of standards for the culture and quality control of olfactory ensheathing cells for use in clinical applications. These guidelines include standardized training and management procedures for laboratory operators; standardized use and management of materials and equipment; standardized collection, culture, and proliferation of OECs obtained from fetal olfactory bulbs; standardized management for cell preservation, transport, and related safeguard measures; and the standardization of a clean environment, routine maintenance, and related tests and examinations. Our goal in publishing this set of standards is to promote the worldwide safety, effectiveness, and replicability of utilizing OECs obtained from fetal olfactory bulbs for neurorestorative clinical application.

Keywords

standardizationcell culturequality contrololfactory ensheathing glial cellsneurorestorative clinical applicationneurorestoratologytranslational medicine

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Journal of Neurorestoratology
Volume 5 Issue 1,
December 2017
Pages 175-179
DOI: 10.2147/JN.S148107
Cite this article:
Xiao J, Chen L, Mao G, et al. Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells. Journal of Neurorestoratology, 2017, 5(1): 175-179. https://doi.org/10.2147/JN.S148107

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Published: 22 September 2017
© 2017 The Author(s).

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