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

Not Applicable

• Conditions: Determine the Therapeutic Efficiency; Correlate the Imaging Results; Characterize and Evaluate Functional After Transplantation
• Interventions: Procedure: BOLD-fMRI drived DTI scanning; Biological: stem cell transplantation

• Registration Number: NCT03336996
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Study First Posted: 2017-11-08
• Last Update Posted: 2017-11-08
• Study Start: 2018-03
• Primary Completion: 2020-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
correlate the imaging results	BOLD-fMRI drived DTI scanning	To correlate the imaging results with the electrophysiology outcomes
evaluation	BOLD-fMRI drived DTI scanning	To characterize and evaluate functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal stem cells transplantation with BOLD drived-DTI
BOLD-fMRI and DTI	stem cell transplantation	To determine the therapeutic efficiency of umbilical cord mesenchymal stem cells and also the utility of the integration of BOLD-fMRI and DTI.

Primary Outcome Measures

Name	Time	Method
BOLD-fMRI drived DTI scanning	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

Name	Time	Method
Motor evoked potential	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;
FIM	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;
NIHSS	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;

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China