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Journal of Neurorestoratology 2020, 8(3): 182-193 https://doi.org/10.26599/JNR.2020.9040019
Research Article | Open Access | Issue | Published: 28 September 2020

Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial

Show Author's Information Yunliang Wang1,12,  Xiaoling Guo2,  Jun Liu3,  Zuncheng Zheng4,  Ying Liu5,6,  Wenyong Gao5,6,  Juan Xiao5,6,  Yanqiu Liu1,  Yan Li2,  Manli Tang3,  Linlin Wang7,  Lin Chen8,  Di Chen6,  Deqiang Guo9,  Fei Liu9,  Weidong Chen10,  Baomin Chan11,  Bo Zhou2,  Aibing Liu5,  Gengsheng Mao5,  Hongyun Huang5,6( )
Neurological Center, 960 Hospital of Chinese PLA, Zibo 255300, Shandong, China
Neurological Department, 981 Hospital of Chinese PLA, Chengde 067000, Hebei, China
Neurological Department, Civil Aviation Guangzhou Hospital, Guangzhou 510405, Guangdong, China
Department of Rehabilitation, Taian Central Hospital, Taian 271000, Shandong, China
Institute of Neurorestoratology, Third Medical Center of General Hospital of PLA, Beijing 100039, China
Beijing Hongtianji Neuroscience Academy, Beijing 100143, China
Institute of Reproductive and Child Health/National Health Commission Key Laboratory of Reproductive Health, School of Public Health, Peking University Health Science Center, Beijing 100191, China
Department of Neurosurgery, Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine, Beijing 100700, China
E.N.T. Department, 960 Hospital of Chinese PLA, Zibo 255300, Shandong, China
E.N.T. Department, 981 Hospital of Chinese PLA, Chengde 067000, Hebei, China
E.N.T. Department, Civil Aviation Guangzhou Hospital, Guangzhou 510405, Guangdong, China
Neurological Department, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450014, Henan, China
Keywords:
olfactory ensheathing cells, Schwann cells, chronic ischemic stroke, cell therapy, randomized control trial
Cite this article:
Wang Y, Guo X, Liu J, et al. Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial. Journal of Neurorestoratology, 2020, 8(3): 182-193. https://doi.org/10.26599/JNR.2020.9040019
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Abstract Full text About this article

Olfactory ensheathing cells (OECs) have shown promising results for patients with neurologic diseases in non-double-blind, placebo control studies. Thirty patients with a unilateral ischemic stroke of more than a year were enrolled in a phase 2, multicenter, randomized, double-blind, and placebo-controlled cell therapy trial with a subsequent 12-month follow-up. The primary therapeutic objective has shown that after 12 months, there were significant differences in National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI) assessment scores among the OEC group, Schwann cell group and placebo medium group at one-year follow-up. The second therapeutic objective found that there were significant differences in NIHSS, mRS, and BI assessment scores when comparing the endpoint data with the baseline data in the OEC group. There was neither hypersensitivity reaction nor adverse event. The results of this multicenter, randomized, double-blind, and placebo-controlled study indicate that injecting OECs into the olfactory sub-mucosa have neurorestorative effects, which can improve the quality of life for patients with chronic ischemic strokes without serious side effects.


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About this article

Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial

Show Author's information Yunliang Wang1,12, Xiaoling Guo2, Jun Liu3, Zuncheng Zheng4, Ying Liu5,6, Wenyong Gao5,6, Juan Xiao5,6, Yanqiu Liu1, Yan Li2, Manli Tang3, Linlin Wang7, Lin Chen8, Di Chen6, Deqiang Guo9, Fei Liu9, Weidong Chen10, Baomin Chan11, Bo Zhou2, Aibing Liu5, Gengsheng Mao5, Hongyun Huang5,6( )
Neurological Center, 960 Hospital of Chinese PLA, Zibo 255300, Shandong, China
Neurological Department, 981 Hospital of Chinese PLA, Chengde 067000, Hebei, China
Neurological Department, Civil Aviation Guangzhou Hospital, Guangzhou 510405, Guangdong, China
Department of Rehabilitation, Taian Central Hospital, Taian 271000, Shandong, China
Institute of Neurorestoratology, Third Medical Center of General Hospital of PLA, Beijing 100039, China
Beijing Hongtianji Neuroscience Academy, Beijing 100143, China
Institute of Reproductive and Child Health/National Health Commission Key Laboratory of Reproductive Health, School of Public Health, Peking University Health Science Center, Beijing 100191, China
Department of Neurosurgery, Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine, Beijing 100700, China
E.N.T. Department, 960 Hospital of Chinese PLA, Zibo 255300, Shandong, China
E.N.T. Department, 981 Hospital of Chinese PLA, Chengde 067000, Hebei, China
E.N.T. Department, Civil Aviation Guangzhou Hospital, Guangzhou 510405, Guangdong, China
Neurological Department, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450014, Henan, China

Abstract

Olfactory ensheathing cells (OECs) have shown promising results for patients with neurologic diseases in non-double-blind, placebo control studies. Thirty patients with a unilateral ischemic stroke of more than a year were enrolled in a phase 2, multicenter, randomized, double-blind, and placebo-controlled cell therapy trial with a subsequent 12-month follow-up. The primary therapeutic objective has shown that after 12 months, there were significant differences in National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI) assessment scores among the OEC group, Schwann cell group and placebo medium group at one-year follow-up. The second therapeutic objective found that there were significant differences in NIHSS, mRS, and BI assessment scores when comparing the endpoint data with the baseline data in the OEC group. There was neither hypersensitivity reaction nor adverse event. The results of this multicenter, randomized, double-blind, and placebo-controlled study indicate that injecting OECs into the olfactory sub-mucosa have neurorestorative effects, which can improve the quality of life for patients with chronic ischemic strokes without serious side effects.

Keywords: olfactory ensheathing cells, Schwann cells, chronic ischemic stroke, cell therapy, randomized control trial

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Publication history
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Publication history

Received: 27 July 2020
Revised: 10 August 2020
Accepted: 25 August 2020
Published: 28 September 2020
Issue date: September 2020

Copyright

© The authors 2020

Acknowledgements

We would like to acknowledge our patients and their families who participated in the trial and made a major contribution to advance knowledge and to the welfare of future stroke patients and their families. We would also like to acknowledge our clinical site investigators and coordinators (Yufu Yan, Yajun Liu, Neifeng Kuang, et al.) who made this trial possible. We thank Prof. Xijing He for his many advisory suggestions to the trial design. We thank Prof. Priscilla Song for polishing language in this manuscript.

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

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