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Protocol | Open Access

Clinical trial of intrathecal injection of protein polymers for apoplexy: A protocol

Lu Diaoa,1Xiaoyan Liua,1Mingze Chaia,1Jianjun Lib,1Yu WangbWenyong GaobHaisheng Liuc( )Mi Liua( )Lin Chenb,d( )
Department of Pharmaceutics, College of Pharmaceutical Sciences, Soochow University, Suzhou 215021, Jiangsu China
Beijing Darwin Cell Biotechnology Co., Ltd., Beijing 100043, China
Shouyi Chinese Medicine Hospital, Beijing 100043, China
Department of Neurosurgery, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100007, China

1 These authors contributed equally to this work.

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Abstract

Protein polymers derived from mesenchymal stem cells, especially human umbilical cord mesenchymal stem cells, showed promising potentials in treating ischemic stroke, thanks to the advantages of selective assembly, targeted delivery, efficient repair of damaged tissues, high safety, highly stable chemical properties, and being easy for storage. Herein, we introduced a clinical trial based on protein polymers derived from human umbilical cord mesenchymal stem cells. The main purpose of this clinical study is to preliminarily verify the safety and efficacy of intrathecal administration and application of protein polymers in clinical treatment of ischemic stroke cases. The summary of the program, the research plan, test protein polymer intrathecal injection method, experimental protein polymer management, patient evaluation index, data management and statistical analysis, technical features, trial schedule etc. are detailed described in the article. This clinical study provides information for other clinical trials based on protein polymers and medicines used to treat apoplexy.

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Journal of Neurorestoratology
Article number: 100052
Cite this article:
Diao L, Liu X, Chai M, et al. Clinical trial of intrathecal injection of protein polymers for apoplexy: A protocol. Journal of Neurorestoratology, 2023, 11(2): 100052. https://doi.org/10.1016/j.jnrt.2023.100052

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Received: 19 September 2022
Revised: 18 January 2023
Accepted: 31 January 2023
Published: 14 April 2023
© 2023 The Authors.

This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

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