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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Characterize and Evaluate Functional After Transplantation, Determine the Therapeutic Efficiency, Correlate the Imaging Results

Intervention / Treatment
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* Biological: stem cell transplantation
* Procedure: BOLD-fMRI drived DTI scanning


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: evaluation<br>To characterize and evaluate functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal stem cells transplantation with BOLD drived-DTI | Procedure: BOLD-fMRI drived DTI scanning<br>* 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.<br>|
| Experimental: BOLD-fMRI and DTI<br>To determine the therapeutic efficiency of umbilical cord mesenchymal stem cells and also the utility of the integration of BOLD-fMRI and DTI. | Biological: stem cell transplantation<br>* the motor nerve fiber damaged patient receive a treatment course stem cell transplantation after the hematoma removal.<br>|
| Experimental: correlate the imaging results<br>To correlate the imaging results with the electrophysiology outcomes | Procedure: BOLD-fMRI drived DTI scanning<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD-fMRI drived DTI scanning | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIM | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor nerve injury, umbilical cord interstitial stem cell, bold-DTI, reconstruction of motor circuits