- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01438593
Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
31. juli 2012 opdateret af: Shinn-Zong Lin, China Medical University Hospital
An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study will use CD34+ cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies).
StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 5 out of 6 HLA (human leukocyte antigens) for transplantation.
The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells.
We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
6
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taichung, Taiwan, 244
- China Medical University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
35 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects can be of either gender and must be between 35 through 75 years of age.
- Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
- Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
- Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-15.
- Subjects must have stroke in the middle cerebral artery territory.
- Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
- Subjects must be able to read and understand the informed consent form that has been approved by the appropriate Institutional Review Board (IRB). The subject must sign and date the informed consent form before any study-specific procedures. (Note: If a subject consents to participation but is not in a position to sign and date the informed consent form personally because of his or her physical conditions, the consent form must be confirmed orally at the time of consent, marked or finger printed by the subject voluntarily). The informed consent procedure must be observed by an independent witness who is present throughout the whole informed consent process and sign the consent form.
Exclusion Criteria:
- Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
- Pregnant or lactating women.
- History of alcohol or drug abuse in the previous 3 months.
Subjects must not have the following conditions in documents:
- significant renal, cardiovascular, hepatic, or psychiatric disease
- abnormal blood coagulation parameters,
- immunodeficiency (e.g. AIDS)
- tumors, leukemia, and other cancer that may interfere with the clinical trial protocol
- infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation.
- Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
- Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
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Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline in NIH Stroke Scale (NIHSS)
Tidsramme: Change from baseline in NIHSS at 1 weeks
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Evaluate change from Baseline in NIHSS at 1 week
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Change from baseline in NIHSS at 1 weeks
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Change from Baseline in NIH Stroke Scale(NIHSS)
Tidsramme: Change from Baseline in NIHSS at 2 weeks
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Evaluate change from Baseline in NIHSS at 2 weeks
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Change from Baseline in NIHSS at 2 weeks
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Change from baseline in NIH Stroke Scale
Tidsramme: Change from baseline in NIHSS at 4 weeks
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Evaluate change from baseline in NIHSS at 4 weeks
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Change from baseline in NIHSS at 4 weeks
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Change from baseline in NIH Stroke Scale ( NIHSS)
Tidsramme: Change from baseline in NIHSS at 12 weeks
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Evaluate change from baseline in NIHSS at 12 weeks
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Change from baseline in NIHSS at 12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline in Brain Image
Tidsramme: Change from baseline in Brain Image at 1 week
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Brain Image will be performed by MRI.
The MRI evaluation includes DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week
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Change from baseline in Brain Image at 1 week
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Change from baseline in Brain Image
Tidsramme: Change from baseline in Brain Image at 4 weeks
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Brain Image will be performed by MRI.
The MRI evaluation includes DEI,T1W,T2W,MRS and DTI , and evaluate the change from baseline at 4 weeks
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Change from baseline in Brain Image at 4 weeks
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Change from baseline in Brain Image
Tidsramme: Change from baseline in Brain Image at 6 months
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Brain Image will be performed by MRI.MRI image includes DEI,T1W, T2W, and DTI, and change from baseline will be evaluated at 6 months.
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Change from baseline in Brain Image at 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Shinn-Zong Lin, M.D.;PhD., China Medical University Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2013
Primær færdiggørelse (Forventet)
1. december 2013
Studieafslutning (Forventet)
1. december 2013
Datoer for studieregistrering
Først indsendt
7. september 2011
Først indsendt, der opfyldte QC-kriterier
21. september 2011
Først opslået (Skøn)
22. september 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2012
Sidst verificeret
1. december 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Nekrose
- Hjerte-kar-sygdomme
- Karsygdomme
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Hjerneinfarkt
- Cerebrale arterielle sygdomme
- Intrakranielle arterielle sygdomme
- Infarkt
- Slag
- Iskæmisk slagtilfælde
- Hjerneiskæmi
- Iskæmi
- Cerebralt infarkt
- Infarkt, mellemhjernearterie
Andre undersøgelses-id-numre
- DMR97-IRB-178-4
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Intercerebral implantation of allogenic CD34+ stem cell
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China Medical University HospitalAfsluttetSlag | MellemhjernearterieinfarktTaiwan