Characterize and Evaluate Functional After TransplantationNCT03336996
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
A study testing stem cell transplantation and BOLD-fMRI drived DTI scanning in people with Characterize and Evaluate Functional After Transplantation and Determine the Therapeutic Efficiency, run by General Hospital of Ningxia Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Characterize and Evaluate Functional After Transplantation, Determine the Therapeutic Efficiency, Correlate the Imaging Results
- What is being tested?
- stem cell transplantation and BOLD-fMRI drived DTI scanning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2018to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
China2 sites
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Xia Hechun, M.D., 8613995109559, xhechun@aliyun.com
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Xia Hechun, M.D., 8613995109559, xHechun@nyfy.com.cn
About this study
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.
Read the 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.
- Conditions
- Characterize and Evaluate Functional After Transplantation, Determine the Therapeutic Efficiency, Correlate the Imaging Results
- Being tested
- stem cell transplantation, BOLD-fMRI drived DTI scanning
- Keywords
- Motor nerve injury, umbilical cord interstitial stem cell, bold-DTI, reconstruction of motor circuits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell transplantationBiological
the motor nerve fiber damaged patient receive a treatment course stem cell transplantation after the hematoma removal.
BOLD-fMRI drived DTI scanningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Biological: stem cell transplantation |
| correlate the imaging results | Experimental | To correlate the imaging results with the electrophysiology outcomes Receives: Procedure: BOLD-fMRI drived DTI scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: After the transplant 6 months
Secondary outcomes (3)
FIM
All patients should receive the function independence evaluation (FIM) after the transplant 6 months , and the grading has the distinct improvement;
Measured: 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;
Measured: 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;
Measured: after the transplant 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study startMar 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Characterize and Evaluate Functional After TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336996
- Sponsor's protocol ID
- Xhechun4
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03336996
- Acronym / sponsor ID
- Xhechun4
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| evaluation | Experimental | Procedure: BOLD-fMRI drived DTI scanningTo 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 | Experimental | Biological: stem cell transplantationTo determine the therapeutic efficiency of umbilical cord mesenchymal stem cells and also the utility of the integration of BOLD-fMRI and DTI. |
| correlate the imaging results | Experimental | Procedure: BOLD-fMRI drived DTI scanningTo correlate the imaging results with the electrophysiology outcomes |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stem cell transplantationthe motor nerve fiber damaged patient receive a treatment course stem cell transplantation after the hematoma removal. | Biological | BOLD-fMRI and DTI |
| BOLD-fMRI drived DTI scanningAll 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. | Procedure or surgery | correlate the imaging results, evaluation |
Primary outcome
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;
3 secondary outcomes
FIM
Time frame: after the transplant 6 months
NIHSS
Time frame: after the transplant 6 months
Motor evoked potential
Time frame: after the transplant 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stem cell transplantation and BOLD-fMRI drived DTI scanning in people with Characterize and Evaluate Functional After Transplantation and Determine the Therapeutic Efficiency, run by General Hospital of Ningxia Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD-fMRI drived DTI scanning (time frame: After the transplant 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.