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

IF 3.1 4区医学 Q2 CLINICAL NEUROLOGY

Journal of Neurorestoratology Pub Date : 2023-06-01 DOI:10.1016/j.jnrt.2023.100052

Lu Diao , Xiaoyan Liu , Mingze Chai , Jianjun Li , Yu Wang , Wenyong Gao , Haisheng Liu , Mi Liu , Lin Chen

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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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鞘内注射蛋白聚合物治疗中风的临床试验:方案

来源于间充质干细胞，特别是人脐带间充质细胞的蛋白质聚合物，由于具有选择性组装、靶向递送、有效修复受损组织、安全性高、化学性质高度稳定和易于储存等优点，在治疗缺血性脑卒中方面显示出良好的潜力。在此，我们介绍了一项基于来源于人脐带间充质干细胞的蛋白质聚合物的临床试验。本临床研究的主要目的是初步验证鞘内给药的安全性和有效性以及蛋白质聚合物在缺血性脑卒中临床治疗中的应用。文章详细介绍了该方案的概述、研究计划、试验蛋白聚合物鞘内注射方法、实验蛋白聚合物管理、患者评价指标、数据管理和统计分析、技术特点、试验时间表等。这项临床研究为其他基于蛋白质聚合物和用于治疗中风的药物的临床试验提供了信息。

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来源期刊

Journal of Neurorestoratology CLINICAL NEUROLOGY-

CiteScore

2.10

自引率

18.20%

发文量

审稿时长

12 weeks