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
6 november 2017 uppdaterad av: General Hospital of Ningxia Medical University
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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ningxia
-
Yinchuan, Ningxia, Kina, 750004
- General Hospital of Ningxia Medical University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: evaluation
To characterize and evaluate functional and anatomical changes of nerve fiber injuries after umbilical cord mesenchymal stem cells transplantation with BOLD drived-DTI
|
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.
|
|
Experimentell: 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.
|
the motor nerve fiber damaged patient receive a treatment course stem cell transplantation after the hematoma removal.
|
|
Experimentell: correlate the imaging results
To correlate the imaging results with the electrophysiology outcomes
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
BOLD-fMRI drived DTI scanning
Tidsram: 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;
|
After the transplant 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
FIM
Tidsram: 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;
|
after the transplant 6 months
|
|
NIHSS
Tidsram: 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;
|
after the transplant 6 months
|
|
Motor evoked potential
Tidsram: 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;
|
after the transplant 6 months
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 mars 2018
Primärt slutförande (Förväntat)
1 mars 2020
Avslutad studie (Förväntat)
1 mars 2021
Studieregistreringsdatum
Först inskickad
26 oktober 2017
Först inskickad som uppfyllde QC-kriterierna
6 november 2017
Första postat (Faktisk)
8 november 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 november 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 november 2017
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Xhechun4
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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