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Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke

31 de julio de 2012 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

6

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Woei-Cherng Shyu, M.D.;PhD.
  • Número de teléfono: 7813 886-4-22052121
  • Correo electrónico: shyu9423@gmail.com

Ubicaciones de estudio

      • Taichung, Taiwán, 244
        • China Medical University Hospital
        • Contacto:
          • Woei-Cherng Shyu, M.D.;PhD.
          • Número de teléfono: 7813 886-4-22052121
          • Correo electrónico: shyu9423@gmail.com
        • Investigador principal:
          • Shinn-Zong Lin, M.D.;PhD.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

35 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Otros nombres:
  • Célula madre hematopoyética
  • Cord Blood Stem Cell
  • UCB Stem Cell

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in NIH Stroke Scale (NIHSS)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in Brain Image
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Shinn-Zong Lin, M.D.;PhD., China Medical University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2013

Finalización primaria (Anticipado)

1 de diciembre de 2013

Finalización del estudio (Anticipado)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

7 de septiembre de 2011

Primero enviado que cumplió con los criterios de control de calidad

21 de septiembre de 2011

Publicado por primera vez (Estimar)

22 de septiembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de agosto de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

31 de julio de 2012

Última verificación

1 de diciembre de 2011

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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