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Trial record 1 of 1 for:    NCT01438593
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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

Tracking Information
First Submitted Date  ICMJE September 7, 2011
First Posted Date  ICMJE September 22, 2011
Last Update Posted Date August 2, 2012
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2011)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
Change from baseline in NIH Stroke Scale (NIHSS) [ Time Frame: Change from baseline in NIHSS at 12 weeks ]
Change from Baseline in NIHSS will be evaluated at 1 week,2 weeks ,4 weeks,12 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2011)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
Change from baseline in Brain Image [ Time Frame: Change from baseline in Brain image at 6 months ]
1.Brain Image will be performed by MRI. And the MRI evaluation will include DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week, 4 weeks, 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
Official Title  ICMJE An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Stroke
  • Ischaemic Cerebral Infarction
  • Infarction, Middle Cerebral Artery
  • Ischemia
  • Brain Ischemia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
Intervention: Procedure: Intercerebral implantation of allogenic CD34+ stem cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2011)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01438593
Other Study ID Numbers  ICMJE DMR97-IRB-178-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shinn-Zong Lin, China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shinn-Zong Lin, M.D.;PhD. China Medical University Hospital
PRS Account China Medical University Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP