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Research Article | Open Access

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

Yunliang Wang1,12Xiaoling Guo2Jun Liu3Zuncheng Zheng4Ying Liu5,6Wenyong Gao5,6Juan Xiao5,6Yanqiu Liu1Yan Li2Manli Tang3Linlin Wang7Lin Chen8Di Chen6Deqiang Guo9Fei Liu9Weidong Chen10Baomin Chan11Bo Zhou2Aibing Liu5Gengsheng Mao5Hongyun 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
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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.

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Journal of Neurorestoratology
Pages 182-193
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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Received: 27 July 2020
Revised: 10 August 2020
Accepted: 25 August 2020
Published: 28 September 2020
© The authors 2020

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

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