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Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

This study has been completed.
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00950521
First received: July 30, 2009
Last updated: April 20, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Stroke
Middle Cerebral Artery Infarction
 Procedure: Intercerebral implantation of Autulogous Stem Cells
Drug: convention therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • NIH-stroke scale (NIHSS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • European stroke scale (ESS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ] [ Designated as safety issue: Yes ]
  • European stroke motor subscale (EMS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Barthel index and Mini-Mental State Examination (MMSE) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Magnetic resonance imaging (MRI) and computed tomography (CT) scans [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Procedure: Intercerebral implantation of Autulogous Stem Cells
2-8 millions Stem cell per patients plus convention therapy
Other Names:
  • PBSC
  • CD34 Stem Cell
Active Comparator: Control
Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication
 Drug: convention therapy
antiplatelet
Other Name: convention therapy

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950521

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Shinn-Zong Lin, MD, DMSci China Medical University Hospital
  More Information

No publications provided by China Medical University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shinn-Zong Lin M.D., Ph.D., Professor of Neurosurgery, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT00950521     History of Changes
Other Study ID Numbers: DMR-96-IRB-145, DOH Approval No:098004365
Study First Received: July 30, 2009
Last Updated: April 20, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Stroke
Stem Cell
Cell Therapy
CD34 Stem cell
Peripheral blood Stem cell

Additional relevant MeSH terms:
Infarction
Stroke
Cerebral Infarction
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on June 18, 2013