Assessement the Reconstruction of Motor Circuits in Nerve Fiber Injuries After the Treatment of Umbilical Cord Mesenchymal Stem Cells With Blood Oxygen Level-dependent Drived Diffusion Tensor Imaging
2017年11月6日 更新者:General Hospital of Ningxia Medical University
Nowadays, the stem cell therapy is a promising method in treatment of the traumatic nerve fiber injuries.
And the clinical use of umbilical cord mesenchymal stem cells has been approved by FDA.
However, the results are inconsistent from both human study and animal research, it often difficult to visualize the reconstruction of the motor circuits.
A separate application of DTI could not precisely reveal white matter integrity.
Combining blood oxygen level-dependent(BOLD)-functional magnetic resonance imaging(fMRI) with diffusion tensor-based tractography (DTT), to detect neural activities in the brain involved in the motor function restore and then using the two seeds method to reconstruct the nerve fibers between these connecting regions.
The main aim of this study: i.
To characterize and evaluate functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal stem cells transplantation with BOLD drived-diffusion tensor imaging(DTI).
ii.
To determine the therapeutic efficiency of umbilical cord mesenchymal stem cells and also the utility of the integration of BOLD-fMRI and DTI.
iii.
To correlate the imaging results with the electrophysiology outcomes.
研究概览
地位
未知
条件
详细说明
The stem cell therapy is a promising method in treatment of the traumatic nerve fiber injuries.
And the clinical use of umbilical cord mesenchymal stem cells has been approved by FDA.
However, the results are inconsistent from both human study and animal research, it often difficult to visualize the reconstruction of the motor circuits.
A separate application of DTI could not precisely reveal white matter integrity.
Combining BOLD-fMRI with diffusion tensor-based tractography (DTT), to detect neural activities in the brain involved in the motor function restore and then using the two seeds method to reconstruct the nerve fibers between these connecting regions.
The main aim of this study: i.
To characterize and evaluate functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal stem cells transplantation with BOLD drived-DTI.
ii.
To determine the therapeutic efficiency of umbilical cord mesenchymal stem cells and also the utility of the integration of BOLD-fMRI and DTI.
iii.
To correlate the imaging results with the electrophysiology outcomes.
研究类型
介入性
注册 (预期的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Ningxia
-
Yinchuan、Ningxia、中国、750004
- General Hospital of Ningxia Medical University
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- All tested patients must be Sobriety and coordination the examination.
- All tested patients with motor nerve fiber damaged must tally with the diagnosis standard which after the head CT, fMRI confirmation and obvious clinical symptoms.
- Patient's age and gender: 20-65years,the gender is not limit;
- All patient's must has one side neurological deficits.
- The patient must receive surgery and stem cell transplantation.
Exclusion Criteria:
- Progressive dysfunction;
- Other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on;
- The patient with tumor in every system on there body;
- Having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm;
- Can not accept MRI inspection, for some metal implant in there body(such as inner support in heart or brain blood vessel)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:evaluation
To characterize and evaluate functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal stem cells transplantation with BOLD drived-DTI
|
All patients should be receive cranial BOLD-fMRI drived DTI scanning scanning separately before the transplant and after the transplant 0, 1, 3, 6 and 12 months.
|
|
实验性的:BOLD-fMRI and DTI
To determine the therapeutic efficiency of umbilical cord mesenchymal stem cells and also the utility of the integration of BOLD-fMRI and DTI.
|
the motor nerve fiber damaged patient receive a treatment course stem cell transplantation after the hematoma removal.
|
|
实验性的:correlate the imaging results
To correlate the imaging results with the electrophysiology outcomes
|
All patients should be receive cranial BOLD-fMRI drived DTI scanning scanning separately before the transplant and after the transplant 0, 1, 3, 6 and 12 months.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BOLD-fMRI drived DTI scanning
大体时间:After the transplant 6 months
|
All patients should be receive cranial BOLD-fMRI drived DTI scanning scanning after the transplant 6 months, and the result tells us that there is obvious reconstruction of motor circuits in nerve fiber on the damaged region;
|
After the transplant 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
FIM
大体时间:after the transplant 6 months
|
All patients should receive the function independence evaluation (FIM) after the transplant 6 months , and the grading has the distinct improvement;
|
after the transplant 6 months
|
|
NIHSS
大体时间:after the transplant 6 months
|
All patients should receive the American State-run Health Research institute apoplexy meter (NIHSS) evaluation after the transplant 6 months , and the grading has the distinct improvement;
|
after the transplant 6 months
|
|
Motor evoked potential
大体时间:after the transplant 6 months
|
All patients should be receive motor evoked potential after the transplant 6 months, and the function of movement and sensation get obvious improvement;
|
after the transplant 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2018年3月1日
初级完成 (预期的)
2020年3月1日
研究完成 (预期的)
2021年3月1日
研究注册日期
首次提交
2017年10月26日
首先提交符合 QC 标准的
2017年11月6日
首次发布 (实际的)
2017年11月8日
研究记录更新
最后更新发布 (实际的)
2017年11月8日
上次提交的符合 QC 标准的更新
2017年11月6日
最后验证
2017年10月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- Xhechun4
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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