- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01438593
Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
31. juli 2012 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert 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
Studietype
Intervensjonell
Registrering (Forventet)
6
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Woei-Cherng Shyu, M.D.;PhD.
- Telefonnummer: 7813 886-4-22052121
- E-post: shyu9423@gmail.com
Studiesteder
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Taichung, Taiwan, 244
- China Medical University Hospital
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Ta kontakt med:
- Woei-Cherng Shyu, M.D.;PhD.
- Telefonnummer: 7813 886-4-22052121
- E-post: shyu9423@gmail.com
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Hovedetterforsker:
- Shinn-Zong Lin, M.D.;PhD.
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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
35 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Shinn-Zong Lin, M.D.;PhD., China Medical University Hospital
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
1. januar 2013
Primær fullføring (Forventet)
1. desember 2013
Studiet fullført (Forventet)
1. desember 2013
Datoer for studieregistrering
Først innsendt
7. september 2011
Først innsendt som oppfylte QC-kriteriene
21. september 2011
Først lagt ut (Anslag)
22. september 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. august 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. juli 2012
Sist bekreftet
1. desember 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Nekrose
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Hjerneinfarkt
- Cerebrale arterielle sykdommer
- Intrakranielle arterielle sykdommer
- Infarkt
- Slag
- Iskemisk hjerneslag
- Hjerneiskemi
- Iskemi
- Cerebralt infarkt
- Infarkt, midtre cerebral arterie
Andre studie-ID-numre
- DMR97-IRB-178-4
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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