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

NCT03336996 | Unknown

• 1 other identifier: Xhechun4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• FIM

  after the transplant 6 months

• NIHSS

  after the transplant 6 months

• Motor evoked potential

  after the transplant 6 months

Study Arms (3)

evaluation

EXPERIMENTAL

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

BOLD-fMRI and DTI

EXPERIMENTAL

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

correlate the imaging results

EXPERIMENTAL

To correlate the imaging results with the electrophysiology outcomes

Procedure: BOLD-fMRI drived DTI scanning

Interventions

stem cell transplantation BIOLOGICAL

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

BOLD-fMRI and DTI

BOLD-fMRI drived DTI scanning 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.

correlate the imaging results; evaluation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (2)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 8, 2017
• Study Start: March 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: November 8, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)