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Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

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ClinicalTrials.gov Identifier: NCT00950521
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : April 21, 2011
Sponsor:
Information provided by:
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE July 30, 2009
First Posted Date  ICMJE July 31, 2009
Last Update Posted Date April 21, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
NIH-stroke scale (NIHSS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00950521 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
  • European stroke scale (ESS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
  • European stroke motor subscale (EMS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
  • Barthel index and Mini-Mental State Examination (MMSE) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
  • Magnetic resonance imaging (MRI) and computed tomography (CT) scans [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients
Official Title  ICMJE Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients
Brief Summary The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.
Detailed Description 30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Middle Cerebral Artery Infarction
Intervention  ICMJE
  • Procedure: Intercerebral implantation of Autulogous Stem Cells
    2-8 millions Stem cell per patients plus convention therapy
    Other Names:
    • PBSC
    • CD34 Stem Cell
  • Drug: convention therapy
    antiplatelet
Study Arms  ICMJE
  • Active Comparator: PBSC Treatment
    Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication
    Intervention: Procedure: Intercerebral implantation of Autulogous Stem Cells
  • Active Comparator: Control
    Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication
    Intervention: Drug: convention therapy
Publications * Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85. Review.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged 35-70 chronic stroke adult patient,
  • with stroke history of more than 6 months, less than 60 months,
  • with stable hemiplegia condition, and
  • NIHSS (NIH Stroke Scale) score is between 9-20.

Exclusion Criteria:

  • patients aged less than 35 or more than 70,
  • hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory,NIHSS is not in the range of 9-20,
  • pregnant women,
  • impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.
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 NCT00950521
Other Study ID Numbers  ICMJE DMR-96-IRB-145
DOH Approval No:098004365
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shinn-Zong Lin M.D., Ph.D., Professor of Neurosurgery, China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shinn-Zong Lin, MD, DMSci China Medical University Hospital
PRS Account China Medical University Hospital
Verification Date April 2011

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