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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

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

      • Taichung, Taiwan, 244
        • China Medical University Hospital
        • Ta kontakt med:
          • Woei-Cherng Shyu, M.D.;PhD.
          • Telefonnummer: 7813 886-4-22052121
          • E-post: shyu9423@gmail.com
        • Hovedetterforsker:
          • Shinn-Zong Lin, M.D.;PhD.

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:

  1. Subjects can be of either gender and must be between 35 through 75 years of age.
  2. Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
  3. Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
  4. 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.
  5. Subjects must have stroke in the middle cerebral artery territory.
  6. Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
  7. 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:

  1. 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.
  2. Pregnant or lactating women.
  3. History of alcohol or drug abuse in the previous 3 months.
  4. 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.
  5. 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.
  6. 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
Eksperimentell: HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
Andre navn:
  • Hematopoetisk stamcelle
  • Cord Blood Stem Cell
  • UCB Stem Cell

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
Evaluate change from Baseline in NIHSS at 1 week
Change from baseline in NIHSS at 1 weeks
Change from Baseline in NIH Stroke Scale(NIHSS)
Tidsramme: Change from Baseline in NIHSS at 2 weeks
Evaluate change from Baseline in NIHSS at 2 weeks
Change from Baseline in NIHSS at 2 weeks
Change from baseline in NIH Stroke Scale
Tidsramme: Change from baseline in NIHSS at 4 weeks
Evaluate change from baseline in NIHSS at 4 weeks
Change from baseline in NIHSS at 4 weeks
Change from baseline in NIH Stroke Scale ( NIHSS)
Tidsramme: Change from baseline in NIHSS at 12 weeks
Evaluate change from baseline in NIHSS at 12 weeks
Change from baseline in NIHSS at 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in Brain Image
Tidsramme: Change from baseline in Brain Image at 1 week
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
Change from baseline in Brain Image at 1 week
Change from baseline in Brain Image
Tidsramme: Change from baseline in Brain Image at 4 weeks
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
Change from baseline in Brain Image at 4 weeks
Change from baseline in Brain Image
Tidsramme: Change from baseline in Brain Image at 6 months
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.
Change from baseline in Brain Image at 6 months

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

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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