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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
      • Contact: Xia Hechun, M.D.; Phone Number: 8613995109559; Email: xHechun@nyfy.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Motor nerve injury; umbilical cord interstitial stem cell; bold-DTI; reconstruction of motor circuits
• Other Study ID Numbers: Xhechun4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No