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Time-optimal control of multiple unmanned aerial vehicles with human control input
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作者 Tao Han Bo Xiao +2 位作者 Xi-Sheng Zhan Jie Wu Hongling Gao 《International Journal of Intelligent Computing and Cybernetics》 EI 2019年第1期138-152,共15页
Purpose–The purpose of this paper is to investigate time-optimal control problems for multiple unmanned aerial vehicle(UAV)systems to achieve predefined flying shape.Design/methodology/approach–Two time-optimal prot... Purpose–The purpose of this paper is to investigate time-optimal control problems for multiple unmanned aerial vehicle(UAV)systems to achieve predefined flying shape.Design/methodology/approach–Two time-optimal protocols are proposed for the situations with or without human control input,respectively.Then,Pontryagin’s minimum principle approach is applied to deal with the time-optimal control problems for UAV systems,where the cost function,the initial and terminal conditions are given in advance.Moreover,necessary conditions are derived to ensure that the given performance index is optimal.Findings–The effectiveness of the obtained time-optimal control protocols is verified by two contrastive numerical simulation examples.Consequently,the proposed protocolscan successfully achieve the prescribed flying shape.Originality/value–This paper proposes a solution to solve the time-optimal control problems for multiple UAV systems to achieve predefined flying shape. 展开更多
关键词 Unmanned aerial vehicle human control input Time-optimal control Pontryagin’s minimum principle
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HUMAN-SIMULATING VEHICLE STEERING CONTROL ALGORITHM 被引量:1
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作者 XU Youchun LI Keqiang +1 位作者 CHANG Ming CHEN Jun 《Chinese Journal of Mechanical Engineering》 SCIE EI CAS CSCD 2006年第2期233-236,共4页
A new vehicle steering control algorithm is presented. Unlike the traditional methods do, the algorithm uses a sigmoid function to describe the principle of the human driver's steering strategy. Based on this functio... A new vehicle steering control algorithm is presented. Unlike the traditional methods do, the algorithm uses a sigmoid function to describe the principle of the human driver's steering strategy. Based on this function, a human simulating vehicle steering model, human-simulating steering control(HS) algorithm is designed. In order to improve the adaptability to different environments, a parameter adaptive adjustment algorithm is presented. This algorithm can online modify the value of the key parameters of the HS real time. HS controller is used on a vehicle equipped with computer vision system and computer controlled steering actuator system, the result from the automatic vehicle steering experiment shows that the HS algorithm gives good performance at different speed, even at the maximum speed of 172 km/h. 展开更多
关键词 human-simulating control Sigmoid function Steering algorithm
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Human Interaction Dynamics for Its Use in Mobile Robotics:Impedance Control for Leader-follower Formation 被引量:12
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作者 Daniel Herrera Flavio Roberti +1 位作者 Marcos Toibero Ricardo Carelli 《IEEE/CAA Journal of Automatica Sinica》 SCIE EI CSCD 2017年第4期696-703,共8页
A complete characterization of the behavior in human-robot interactions(HRI) includes both: the behavioral dynamics and the control laws that characterize how the behavior is regulated with the perception data. In thi... A complete characterization of the behavior in human-robot interactions(HRI) includes both: the behavioral dynamics and the control laws that characterize how the behavior is regulated with the perception data. In this way, this work proposes a leader-follower coordinate control based on an impedance control that allows to establish a dynamic relation between social forces and motion error. For this, a scheme is presented to identify the impedance based on fictitious social forces, which are described by distance-based potential fields.As part of the validation procedure, we present an experimental comparison to select the better of two different fictitious force structures. The criteria are determined by two qualities: least impedance errors during the validation procedure and least parameter variance during the recursive estimation procedure.Finally, with the best fictitious force and its identified impedance,an impedance control is designed for a mobile robot Pioneer 3AT,which is programmed to follow a human in a structured scenario.According to results, and under the hypothesis that moving like humans will be acceptable by humans, it is believed that the proposed control improves the social acceptance of the robot for this kind of interaction. 展开更多
关键词 human modeling human-machine interaction impedance control robot dynamics social robotics
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Investigations on serviceability control of long-span structures under human-induced excitation 被引量:3
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作者 Chen Xin Ding Youliang +2 位作者 Li Ai-qun Zhang Zhiqiang Sun Peng 《Earthquake Engineering and Engineering Vibration》 SCIE EI CSCD 2012年第1期57-71,共15页
The increasing strength of new structural materials and the span of new structures, accompanied by aesthetic requirements for greater slenderness, are resulting in more applications of long-span structures. In this pa... The increasing strength of new structural materials and the span of new structures, accompanied by aesthetic requirements for greater slenderness, are resulting in more applications of long-span structures. In this paper, serviceability control technology and its design theory are studied. First, a novel tuned mass damper (TMD) with controllable stiffness is developed. Second, methods for modeling human-induced loads are proposed, including standing up, walking, jumping and running, and an analysis method for long-span floor response is proposed based on a finite element model. Third, a design method for long-span floors installed with a multiple TMD (MTMD) system considering human comfort is introduced, largely based on a study of existing literature. Finally, a design, analysis and field test is conducted using several large scale buildings in China including the Beijing Olympic Park National Conference Center, Changsha New Railway Station and the Xi'an Northern Railway Station. The analytical and field test results show that the MTMD system designed using the proposed method is capable of effectively mitigating the vertical vibration of long-span floor structures. The study presented in this paper provides an important reference for the analysis of vibration serviceability of similar long-span floors and design of control system for these structures. 展开更多
关键词 long-span floor vibration control TMD human-inducing loads vibration serviceability
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Human Resource Controlling and Human Resource Management: Practice of Small and Medium-Sized Building Companies in the Czech Republic
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作者 Filip Busina Martin Sikyr 《Journal of Modern Accounting and Auditing》 2014年第9期983-990,共8页
The aim of this paper is to define the nature, present the possibilities, and discuss the problems of using human resource controlling in small and medium-sized building companies. This paper is based on the assumptio... The aim of this paper is to define the nature, present the possibilities, and discuss the problems of using human resource controlling in small and medium-sized building companies. This paper is based on the assumption that expedient human resource controlling is an effective human resource management tool that achieves the required performance of employees and expected competitiveness of a building company. This paper uses the results of a questionnaire survey conducted in November 2013 to analyze human resource management in building companies in the Czech Republic and specify the organization and conditions of human resource management. Some 81 small (less than 50 employees) and 66 medium-sized (50-249 employees) building companies operating in the Czech Republic took part in the questionnaire survey. The results of the questionnaire survey showed the lack of concept and random nature of human resource management in most small and medium-sized building companies. Of course, in terms of the present economic trend, it is above all important for small and medium-sized companies to develop their adaptability to the building market and to be able to deal with a variety of construction works. It is effective human resource management supported by expedient human resources that serves this purpose. 展开更多
关键词 human resource management human resource controlling building industry small and medium-sizedcompanies
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Fuzzy Simulation Human Intelligent Control System Design on Gyratory Breaker
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作者 Wen,Ruchun Zhao,Shuling Zhu,Jianwu Wang,Xiaoyan 《微计算机信息》 北大核心 2005年第1期11-12,共2页
In order to deal with the complex process that incurs serious time delay, enormous inertia and nonlinear problems, fuzzy simulation human intelligent control algorithm rules are established. The fuzzy simulation human... In order to deal with the complex process that incurs serious time delay, enormous inertia and nonlinear problems, fuzzy simulation human intelligent control algorithm rules are established. The fuzzy simulation human intelligent controller and the hardware with the single-chip microcomputer are designed and the anti-interference measures to the whole system are provided. 展开更多
关键词 模糊控制 人工智能模拟控制 旋转断路器 单芯片微计算机
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Theoretical and practical exploration of vision building in human influenza pandemic prevention & control
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作者 Peng Kong Yan Kong +1 位作者 Xu Jiang Xiaohua Wang 《Asian Pacific Journal of Tropical Medicine》 SCIE CAS 2010年第11期913-916,共4页
This article introduced the vision building concept about human influenza pandemic prevention and control.Different visions were built by creating different shapes of building blocks which also represented different o... This article introduced the vision building concept about human influenza pandemic prevention and control.Different visions were built by creating different shapes of building blocks which also represented different organizations and physical facilities,respectively.The around-view reflection is required to be developed in the process of building so as to search for the ideal pattern.The correlation of all sectors and systems are established to combine different kinds of things,from one family to another,from communities,towns,counties,cities,rural areas, provinces to the state to handle trivial problems.These training objectives have been successfully accomplished,which has not only enriched the knowledge about prevention and control of influenza pandemic between different departments but also clarified the roles and responsibility. It lays the firm foundation for next cooperation between different departments,and make a bridge for the objective and choice of channel over human influenza pandemic prevention and control. 展开更多
关键词 VISION BUILDING human INFLUENZA PANDEMIC PREVENTION and control
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Model reference adaptive impedance control for physical human-robot interaction 被引量:2
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作者 Bakur ALQAUDI Hamidreza MODARES +3 位作者 Isura RANATUNGA Shaikh M. TOUSIF Frank L. LEWIS Dan O. POPA 《Control Theory and Technology》 EI CSCD 2016年第1期68-82,共15页
This paper presents a novel enhanced human-robot interaction system based on model reference adaptive control. The presented method delivers guaranteed stability and task performance and has two control loops. A robot... This paper presents a novel enhanced human-robot interaction system based on model reference adaptive control. The presented method delivers guaranteed stability and task performance and has two control loops. A robot-specific inner loop, which is a neuroadaptive controller, learns the robot dynamics online and makes the robot respond like a prescribed impedance model. This loop uses no task information, including no prescribed trajectory. A task-specific outer loop takes into account the human operator dynamics and adapts the prescribed robot impedance model so that the combined human-robot system has desirable characteristics for task performance. This design is based on model reference adaptive control, but of a nonstandard form. The net result is a controller with both adaptive impedance characteristics and assistive inputs that augment the human operator to provide improved task performance of the human-robot team. Simulations verify the performance of the proposed controller in a repetitive point-to-point motion task. Actual experimental implementations on a PR2 robot further corroborate the effectiveness of the approach. 展开更多
关键词 human-robot interaction model reference adaptive control model reference neuroadaptive impedance control
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Fractional Order Modeling of Human Operator Behavior with Second Order Controlled Plant and Experiment Research 被引量:2
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作者 Jiacai Huang Yang Quan Chen +1 位作者 Haibin Li Xinxin Shi 《IEEE/CAA Journal of Automatica Sinica》 SCIE EI 2016年第3期271-280,279-280+272-278,共10页
Modeling human operator's dynamics plays a very important role in the manual closed-loop control system, and it is an active research area for several decades. Based on the characteristics of human brain and behav... Modeling human operator's dynamics plays a very important role in the manual closed-loop control system, and it is an active research area for several decades. Based on the characteristics of human brain and behavior, a new kind of fractional order mathematical model for human operator in single-input single-output (SISO) systems is proposed. Compared with the traditional models based on the commonly used quasilinear transfer function method or the optimal control theory method, the proposed fractional order model has simpler structure with only few parameters, and each parameter has explicit physical meanings. The actual data and experiment results with the second-order controlled plant illustrate the effectiveness of the proposed method. © 2014 Chinese Association of Automation. 展开更多
关键词 CALCULATIONS Closed loop control systems Mathematical operators
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Matlab Based Human & Hardware-in-Loop Simulation for the Study on Vehicle Stability Control 被引量:1
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作者 张勇 殷承良 张建武 《Journal of Shanghai Jiaotong university(Science)》 EI 2006年第4期498-505,共8页
This paper described an effective method to implement human & hardware in the loop simulation(HHILS), which is based on MATLAB system and can be used to study human driving actions in the abrupt situation and vehi... This paper described an effective method to implement human & hardware in the loop simulation(HHILS), which is based on MATLAB system and can be used to study human driving actions in the abrupt situation and vehicle stability control(VSC). A hybrid control algorithm, which makes full use of the advantages of robust control and fuzzy logic, was adopted in VSC system. The results of HHILS show that HHILS’ application on the vehicle handling and VSC resarch is feasible. These results also confirm that the handling performance of the vehicle with VSC is improved obviously compared to the vehicle without VSC. 展开更多
关键词 human & HARDWARE-IN-LOOP simulation vehicle stability control robust-fuzzy control MATLAB XPC target virtual REALITY
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Human Resource Management:A Case Study of the Air Traffic Controller Strike in 1981
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作者 GAI Ke-ke PAN Jing 《中国管理信息化》 2009年第15期61-65,共5页
The article discusses several hemispheres of human resource management based on a typical case review. The study presents the main problems of the case from both employees and organizations; the issued problems involv... The article discusses several hemispheres of human resource management based on a typical case review. The study presents the main problems of the case from both employees and organizations; the issued problems involve compensations and benefits,restructuring,job design,and training. Based on the analysis of the case,two alternative solutions state that the potential routes for the organizations to avoid serious negative results. The study introduces a number of recommendations that can be used as a reference for other organizations to avoid similar risks. 展开更多
关键词 人力资源管理 信息化建设 流量控制 风险
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一种驾驶目标动态调整的人机博弈共驾方法
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作者 王宪彬 包文龙 +2 位作者 徐砚卿 韩秋圆 张英哲 《汽车工程》 北大核心 2026年第2期361-375,共15页
为解决智能汽车人机协同路径跟踪控制时的驾驶目标冲突问题,实现驾驶员和辅助系统驾驶目标的动态调整,本文提出了一种基于非合作纳什博弈的人机驾驶目标动态调整方法。首先,基于车辆单轨动力学模型,采用非合作纳什博弈理论系统,建立驾... 为解决智能汽车人机协同路径跟踪控制时的驾驶目标冲突问题,实现驾驶员和辅助系统驾驶目标的动态调整,本文提出了一种基于非合作纳什博弈的人机驾驶目标动态调整方法。首先,基于车辆单轨动力学模型,采用非合作纳什博弈理论系统,建立驾驶员和AFS、ARS三者共同在环的人机共驾系统模型,并分别赋予驾驶员、AFS以路径跟踪精度为核心的驾驶目标,赋予ARS以侧向稳定性为核心的驾驶目标。其次,建立系统预测模型,得到三者成本函数。再次,在非合作博弈框架下,提出了基于驾驶目标权重矩阵更新的人机控制权重R更新策略,并求解了三者博弈下的纳什均衡解。最后,通过联合仿真试验验证了该博弈共驾方法在恶劣工况下协调路径跟踪精度与侧向稳定性的优势。 展开更多
关键词 人机共驾 非合作博弈 驾驶目标权重矩阵 人机控制权重 路径跟踪和稳定性控制
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人机协作创作的著作权问题:作者、作品及其可赋权性界限
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作者 高莉 《法治现代化研究》 2026年第1期148-162,共15页
生成式人工智能正驱动未来文化创新创造的范式变革,并加速向人类创作和内容产业领域应用渗透,推动形成人机协作创作新模式。人机协作创作解构了“作者—创作—作品”的线性链条,重构了“人类干预—机器生成”的二元结构,这必然对既有著... 生成式人工智能正驱动未来文化创新创造的范式变革,并加速向人类创作和内容产业领域应用渗透,推动形成人机协作创作新模式。人机协作创作解构了“作者—创作—作品”的线性链条,重构了“人类干预—机器生成”的二元结构,这必然对既有著作权保护理念及判定规则产生极大冲击。在主体构造上,人机协作模式塑造了法律主体(权利主体)与虚拟主体(机器行为体)共存的格局。为此,须凭借人类干预因素来厘定人类作者身份,以此作为人机协作创作成果的可赋权性基础;同时认可机器行为体的虚拟主体地位,以防止版权保护延及纯粹的人工智能(_(AI))生成内容,亦避免忽视AI技术迭变而陷入工具主义的窠臼。对人机协作创作物的作品属性认定,应以类型化为基础展开分析,并采用控制性与独创性的双重标准,确保不悖作品独创性涵摄于主体框架之中的著作权赋权逻辑。人机协作创作的利益权利化,关涉文化创作主体和样态的多样化发展等社会价值,要通过完善配套制度实现社会公平分配和利益平衡。 展开更多
关键词 人机协作创作 控制性标准 可赋权性界限
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美国对华出口管制与企业人力资本升级
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作者 周申 李祈霖 《经济经纬》 北大核心 2026年第1期57-70,共14页
基于2011—2022年A股上市公司员工特征数据与美国实体清单数据,采用多期双重差分模型,探究美国出口管制实体清单对企业人力资本升级影响。研究发现:被列入实体清单显著降低了企业高技能劳动力占比,不利于企业人力资本升级,并且这一负面... 基于2011—2022年A股上市公司员工特征数据与美国实体清单数据,采用多期双重差分模型,探究美国出口管制实体清单对企业人力资本升级影响。研究发现:被列入实体清单显著降低了企业高技能劳动力占比,不利于企业人力资本升级,并且这一负面影响具有长期持续增强趋势;作用机制检验表明,实体清单主要通过强化资金约束效应、弱化市场竞争效应两个渠道对受限企业的人力资本结构产生负面影响;异质性分析发现,对于非创新型企业、所在地区对外开放程度低的企业、国有企业及董事没有海外经验的企业,实体清单对人力资本结构的负面冲击更明显。研究丰富了美国对华出口管制的微观影响研究,也为如何应对贸易摩擦对就业结构的负面影响提供了决策参考。 展开更多
关键词 贸易摩擦 出口管制 实体清单 人力资本 资金约束 市场竞争
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数实产业技术融合与审计定价——基于中国A股上市公司的经验证据
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作者 许宁宁 刘婷 《上海财经大学学报(哲学社会科学版)》 北大核心 2026年第1期66-81,共16页
数实产业技术融合是实体经济高质量发展的重要驱动力,而审计师能否将其纳入风险评估过程,进而调整审计定价决策值得关注。文章基于2008—2022年沪深A股上市公司经验数据,探究审计师定价决策是否因客户数实产业技术融合程度的不同而有所... 数实产业技术融合是实体经济高质量发展的重要驱动力,而审计师能否将其纳入风险评估过程,进而调整审计定价决策值得关注。文章基于2008—2022年沪深A股上市公司经验数据,探究审计师定价决策是否因客户数实产业技术融合程度的不同而有所差异。研究发现,数实产业技术融合与审计收费存在倒U形关系,即随着企业数实产业技术融合程度由低到高转变,审计收费呈现“先增大、后减小”的倒U形演变规律;上述非线性效应在高管技术能力低、风险资本持股比例低以及位于数字基础设施建设水平较低区域的企业更为明显,并随着审计师行业专长的提高而减弱;数实产业技术融合对企业经营风险、内控风险以及事务所数字化人力资本投入、时间投入产生倒U形影响,成为数实产业技术融合导致审计收费非线性变化的重要路径;数实产业技术融合对审计师关键审计事项消极语调亦存在倒U形影响。研究结论对推进数实产业技术在微观企业层面的融合、优化审计定价策略以及加快事务所数智化建设具有借鉴价值。 展开更多
关键词 数实产业技术融合 审计费用 事务所数字化人力资本 内部控制
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工业互联网赋能制造业企业高质量发展——基于工业互联网示范项目的准自然实验
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作者 李梦玄 左钉钉 鞠兴武 《工业技术经济》 北大核心 2026年第2期144-152,共9页
作为新一代信息技术与制造业深度融合的关键载体,工业互联网成为推动制造业转型升级、培育新质生产力的重要抓手。本文以工业互联网示范项目为准自然实验,基于2012~2023年中国A股制造业企业数据,探究工业互联网对制造业企业高质量发展... 作为新一代信息技术与制造业深度融合的关键载体,工业互联网成为推动制造业转型升级、培育新质生产力的重要抓手。本文以工业互联网示范项目为准自然实验,基于2012~2023年中国A股制造业企业数据,探究工业互联网对制造业企业高质量发展的影响效应及作用机制。研究发现,入选工业互联网(尤其是平台类)示范项目显著促进了制造业企业高质量发展,该效应主要通过劳动赋能优化人力资本结构、通过管理赋能降低内部管控成本、通过价值赋能提升附加值创造水平这3条路径得以实现。此外,工业互联网对行业竞争程度更大、非劳动密集型及大规模企业的赋能效应更为显著,说明其重构资源配置的作用在当前阶段仍存在显著的条件性。本文研究为明确企业转型路径与落实制造强国战略提供了充分的理论依据与针对性建议。 展开更多
关键词 工业互联网示范项目 制造业企业 高质量发展 多时点DID 新质生产力 人力资本结构 内部管控成本 附加值创造
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人工智能武器的国际规则建构路径探析
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作者 居梦 周静 《西部学刊》 2026年第1期67-71,共5页
现有国际法难以适应人工智能武器责任归属模糊的技术特性,全球治理机制碎片化且滞后,大国政治博弈严重阻碍共识构建,其根源在于技术伦理矛盾、地缘政治竞争与规范理论滞后。因此,提出构建多层次治理框架、推进国际法律体系改革、创新全... 现有国际法难以适应人工智能武器责任归属模糊的技术特性,全球治理机制碎片化且滞后,大国政治博弈严重阻碍共识构建,其根源在于技术伦理矛盾、地缘政治竞争与规范理论滞后。因此,提出构建多层次治理框架、推进国际法律体系改革、创新全球协作机制的解决方案,在技术层推动透明算法与构建人类监督机制,在操作层建立分级控制标准,制度层建构多元监督与国家问责机制;通过修订国际人道法、制定专项条约实现法律体系适应性改革;创新多利益攸关方协作平台,促进“软法”与“硬法”协同。 展开更多
关键词 人工智能武器 国际规则 技术治理 全球治理 人类控制
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一种由导纳修正的最优人机交互速度变形方法
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作者 杨泽 张世武 《传感器与微系统》 北大核心 2026年第1期167-171,共5页
为了提高物理人机交互的柔顺性和稳定性,针对阻抗控制方法容易产生震荡、需要操作者施加额外力等问题,开发并验证了一种基于约束最优化的物理人机交互方法。通过设计并求解约束优化问题,求解人机交互后一段时间内的机器人运动参考速度,... 为了提高物理人机交互的柔顺性和稳定性,针对阻抗控制方法容易产生震荡、需要操作者施加额外力等问题,开发并验证了一种基于约束最优化的物理人机交互方法。通过设计并求解约束优化问题,求解人机交互后一段时间内的机器人运动参考速度,并保证这段速度有最优的人机交互性能。借助导纳模型进一步修正机器人参考速度,使机器人对人机交互力的响应更符合自然接触关系。在单关节人机交互平台的验证实验中,约束最优化方法显著降低了机器人在响应人体运动过程中的抖动,在保证稳定性的前提下提升了机器人的顺应性。 展开更多
关键词 物理人机交互 阻抗控制 约束最优化
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智能外骨骼手指康复机器人设计
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作者 韩鑫源 李鹏 +4 位作者 赵淑煜 李宗一 张之航 李睿智 赫东锋 《科学技术创新》 2026年第4期221-224,共4页
本文针对手功能障碍患者的康复需求,设计了一种手指康复机器人系统。该设计结合了机械结构、控制系统和人机交互界面,旨在提供安全、有效和个性化的康复训练方案。通过系统设计、硬件实现和软件算法开发,构建了完整的机器人系统。机器... 本文针对手功能障碍患者的康复需求,设计了一种手指康复机器人系统。该设计结合了机械结构、控制系统和人机交互界面,旨在提供安全、有效和个性化的康复训练方案。通过系统设计、硬件实现和软件算法开发,构建了完整的机器人系统。机器人采用模块化设计,可适应不同患者的需求。控制系统基于Arduino主控制器,实现了精确的运动控制。人机交互界面提供直观的操作体验和实时反馈。通过实验验证,该系统能够有效辅助患者进行手指康复训练,为手功能障碍康复提供了新的解决方案。 展开更多
关键词 手指康复 机器人设计 Arduino控制 人机交互 康复训练
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Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial 被引量:10
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作者 Yang Yang Mao Pang +5 位作者 Yu-Yong Chen Liang-Ming Zhang Hao Liu Jun Tan Bin Liu Li-Min Rong 《Neural Regeneration Research》 SCIE CAS CSCD 2020年第8期1532-1538,共7页
Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin... Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019. 展开更多
关键词 clinical study early chronic phase efficacy human umbilical cord mesenchymal stem cell multicenter trial prospective study randomized controlled trial safety spinal cord injury study protocol
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