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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

NCT ID: NCT03336996

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2021-03-31

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.

Conditions

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

Keywords

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Motor nerve injury umbilical cord interstitial stem cell bold-DTI reconstruction of motor circuits

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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evaluation

To characterize and evaluate functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal stem cells transplantation with BOLD drived-DTI

Group Type EXPERIMENTAL

BOLD-fMRI drived DTI scanning

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

stem cell transplantation

Intervention Type BIOLOGICAL

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

correlate the imaging results

To correlate the imaging results with the electrophysiology outcomes

Group Type EXPERIMENTAL

BOLD-fMRI drived DTI scanning

Intervention Type PROCEDURE

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.

Interventions

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stem cell transplantation

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

Intervention Type BIOLOGICAL

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Countries

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China

Facility Contacts

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Xia Hechun, M.D.

Role: primary

Xia Hechun, M.D.

Role: primary

Other Identifiers

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Xhechun4

Identifier Type: -

Identifier Source: org_study_id