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

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ClinicalTrials.gov Identifier: NCT01438593
Recruitment Status : Unknown
Verified December 2011 by Shinn-Zong Lin, China Medical University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2011
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Shinn-Zong Lin, China Medical University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Ischaemic Cerebral Infarction Infarction, Middle Cerebral Artery Ischemia Brain Ischemia Procedure: Intercerebral implantation of allogenic CD34+ stem cell Phase 1

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
Study Start Date : January 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
 Procedure: Intercerebral implantation of allogenic CD34+ stem cell
Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
Other Names:
  • Hematopoietic stem cell
  • Cord Blood Stem Cell
  • UCB Stem Cell


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in NIH Stroke Scale (NIHSS) [ Time Frame: Change from baseline in NIHSS at 1 weeks ]
    Evaluate change from Baseline in NIHSS at 1 week

  2. Change from Baseline in NIH Stroke Scale(NIHSS) [ Time Frame: Change from Baseline in NIHSS at 2 weeks ]
    Evaluate change from Baseline in NIHSS at 2 weeks

  3. Change from baseline in NIH Stroke Scale [ Time Frame: Change from baseline in NIHSS at 4 weeks ]
    Evaluate change from baseline in NIHSS at 4 weeks

  4. Change from baseline in NIH Stroke Scale ( NIHSS) [ Time Frame: Change from baseline in NIHSS at 12 weeks ]
    Evaluate change from baseline in NIHSS at 12 weeks


Secondary Outcome Measures :
  1. Change from baseline in Brain Image [ Time Frame: 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

  2. Change from baseline in Brain Image [ Time Frame: 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

  3. Change from baseline in Brain Image [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438593


Contacts
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Contact: Woei-Cherng Shyu, M.D.;PhD. 886-4-22052121 ext 7813 Shyu9423@gmail.com

Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan, 244
Contact: Woei-Cherng Shyu, M.D.;PhD.    886-4-22052121 ext 7813    shyu9423@gmail.com   
Principal Investigator: Shinn-Zong Lin, M.D.;PhD.         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Shinn-Zong Lin, M.D.;PhD. China Medical University Hospital
More Information
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Responsible Party: Shinn-Zong Lin, Professor of Neurosurgery, China Medical University, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01438593    
Other Study ID Numbers: DMR97-IRB-178-4
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: December 2011
Keywords provided by Shinn-Zong Lin, China Medical University Hospital:
Stroke
Brain disease
Ischemia
Cerebral infraction
Cord Blood
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Brain Ischemia
Infarction, Middle Cerebral Artery
Ischemia
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Brain Infarction
Cerebral Arterial Diseases
Intracranial Arterial Diseases