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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

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ClinicalTrials.gov Identifier: NCT03336996
Recruitment Status : Not yet recruiting
First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Characterize and Evaluate Functional After Transplantation Determine the Therapeutic Efficiency Correlate the Imaging Results Biological: stem cell transplantation Procedure: BOLD-fMRI drived DTI scanning Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: evaluation
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
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.

Experimental: 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.
Biological: stem cell transplantation
the motor nerve fiber damaged patient receive a treatment course stem cell transplantation after the hematoma removal.

Experimental: correlate the imaging results
To correlate the imaging results with the electrophysiology outcomes
Procedure: BOLD-fMRI drived DTI scanning
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.




Primary Outcome Measures :
  1. BOLD-fMRI drived DTI scanning [ Time Frame: 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;


Secondary Outcome Measures :
  1. FIM [ Time Frame: 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;

  2. NIHSS [ Time Frame: 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;

  3. Motor evoked potential [ Time Frame: 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;



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All tested patients must be Sobriety and coordination the examination.
  2. 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.
  3. Patient's age and gender: 20—65years,the gender is not limit;
  4. All patient's must has one side neurological deficits.
  5. The patient must receive surgery and stem cell transplantation.

Exclusion Criteria:

  1. Progressive dysfunction;
  2. Other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on;
  3. The patient with tumor in every system on there body;
  4. Having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm;
  5. Can not accept MRI inspection, for some metal implant in there body(such as inner support in heart or brain blood vessel)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336996


Locations
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China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Xia Hechun, M.D.    8613995109559    xhechun@aliyun.com   
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Xia Hechun, M.D.    8613995109559    xHechun@nyfy.com.cn   
Sponsors and Collaborators
General Hospital of Ningxia Medical University

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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT03336996     History of Changes
Other Study ID Numbers: Xhechun4
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by General Hospital of Ningxia Medical University:
Motor nerve injury
umbilical cord interstitial stem cell
bold-DTI
reconstruction of motor circuits