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Journal of Neurorestoratology  2018, Vol. 6 Issue (1): 74-80    doi: 10.26599/JNR.2018.9040002
Clinical Trial Design     
Neurorestorative effect of olfactory ensheathing cells and Schwann cells by intranasal delivery for patients with ischemic stroke: design of a multicenter randomized double-blinded placebo-controlled clinical study
Gengsheng Mao1,2,(✉), Yunliang Wang3, Xiaoling Guo4, Jun Liu5, Zuncheng Zheng6, Lin Chen7
1 Institute of Neurorestoratology, General Hospital of Chinese people’s Armed Police Forces, Beijing 100039, China
2 Beijing Hongtianji Neuroscience Academy, Beijing 100043, China
3 Neuorlogical Center, 148 Hospital of Chinese PLA, Zhibo of Shandong, China
4 Neurological Department, 266 Hospital of Chinese PLA, Chengde of Hebei, China
5 Neurological Department, Civil Aviation Guangzhou Hospital
6 Department of rehabilitation, Taian Central Hospital, Taian of Shadong, China
7 Department of Neurosurgery,Tsinghua University Yuquan Hospital
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Abstract  Introduction:

There have been many clinical studies or trials for patients with ischemic stroke by cell therapy, which includes olfactory ensheathing cell (OEC), mononuclear cell, mesenchymal stromal cell, fetal neural cell or products of varying stem cells, etc. Those cells through different transplanting ways have showed moderate neurorestorative effect in patients with ischemic stroke, but majority were not multicenter randomized, double-blinded, placebo-controlled studies or trials. OEC transplantation has shown a more effective to restore neurological damage in central nervous system (CNS). We hypothesize that OEC through intra-olfactory mucosa transplantation can migrate into the ischemic stroke area around and restore neurological deficit caused from this disaster.

Objective of the study:

This is a multicenter, randomized, double-blinded, placebo- controlled 12 month clinical study of OECs and Schwann cells (SCs) for patients with sub-acute ischemic stroke and chronic ischemic stroke, to test which kind of cell has more neurorestorative effect for patients with ischemic stroke relative to placebo.

Design of the study:

This study is involved two groups of patients with sub-acute ischemic stroke and chronic ischemic stroke. Each group enrolls 30 patients. The experimental intervention consists in using OECs and SCs through intra-olfactory mucosa transplantation in participating patients. This will be compared with using placebo (injecting cell culture medium). Participating patients in groups of sub-acute ischemic stroke and chronic ischemic stroke are randomized in natural order to divide into A, B, or C groups and get one of experimental treatment procedures. Patients, operating physicians, and assessing physicians are left unaware of what cells or medium will be injected to participating patients. All patients will be assessed before treatment and after one month, three months, six months, and one year.

Ethics and dissemination:

The clinical study protocol and consent form were approved by Chinese Association of Neurorestoratology and the ethics committees of the hospitals which joined this clinical study. Findings will be published in peer-reviewed journals.



Key wordsneurorestorative effect      cell therapy      stroke      olfactory ensheathing cell      schwann cell,neurorestoratology     
Received: 26 November 2017      Published: 25 June 2018
Corresponding Authors: Gengsheng Mao   
Cite this article:

Gengsheng Mao, Yunliang Wang, Xiaoling Guo, Jun Liu, Zuncheng Zheng, Lin Chen. Neurorestorative effect of olfactory ensheathing cells and Schwann cells by intranasal delivery for patients with ischemic stroke: design of a multicenter randomized double-blinded placebo-controlled clinical study. Journal of Neurorestoratology, 2018, 6: 74-80.

URL:

http://jnr.tsinghuajournals.com/10.26599/JNR.2018.9040002     OR     http://jnr.tsinghuajournals.com/Y2018/V6/I1/74

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