- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03336996
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 oppdatert 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ningxia
-
Yinchuan, Ningxia, Kina, 750004
- General Hospital of Ningxia Medical University
-
Ta kontakt med:
- Xia Hechun, M.D.
- Telefonnummer: 8613995109559
- E-post: xHechun@nyfy.com.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Eksperimentell: 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.
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
BOLD-fMRI drived DTI scanning
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
FIM
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. mars 2018
Primær fullføring (Forventet)
1. mars 2020
Studiet fullført (Forventet)
1. mars 2021
Datoer for studieregistrering
Først innsendt
26. oktober 2017
Først innsendt som oppfylte QC-kriteriene
6. november 2017
Først lagt ut (Faktiske)
8. november 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. november 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Xhechun4
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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