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Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke

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ClinicalTrials.gov Identifier: NCT01714167
Recruitment Status : Unknown
Verified June 2015 by Qichuan Zhuge, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : October 25, 2012
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
University of North Texas Health Science Center
Information provided by (Responsible Party):
Qichuan Zhuge, Wenzhou Medical University

Study Description
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Brief Summary:
Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

Condition or disease Intervention/treatment Phase
Stroke Genetic: intracerebral stem cell transplantation Phase 1

Detailed Description:
For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke. The neurological outcome will be determined after transplantation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke
Study Start Date : June 2012
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: intracerebral stem cell transplantation
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation
 Genetic: intracerebral stem cell transplantation
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
No Intervention: conventional treatment
Control group receive conventional stroke treatment that include rehabilitation


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in NIH Stroke Scale at 12 months [ Time Frame: 1, 6 and 12 months ]

Secondary Outcome Measures :
  1. Improvement of infarct size measured by brain MRI [ Time Frame: 1,6 and 12 months after transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 40-70 ischemia stroke or intracerebral hemorrhage patient
  • With stroke history of more than 3 months, less than 60 months
  • With stable hemiplegia condition
  • NIHSS (NIH stroke scale) score of 7 or more points
  • Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria:

  • Patients aged less than 40 or more than 70
  • Lacunar infarction
  • History of neurological disease, head injury or psychiatric disorder with disablity
  • Pregnant women
  • Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition
  • Inaccessibility for follow up
  • Unwillingness to provide written informed consent
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): NCT01714167


Contacts
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Contact: Qichuan Zhuge, M.D. zhugeqichuan@vip.163.com

Locations
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China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 32500
Sponsors and Collaborators
Wenzhou Medical University
University of North Texas Health Science Center
Investigators
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Study Director: Kunlin Jin, M.D., Ph.D. University of North Texas Health Science Center
Study Chair: Qichuan Zhuge, M.D. First Affiliated Hospital of Wenzhou Medical University
More Information
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Responsible Party: Qichuan Zhuge, Department of Neurosurgery, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01714167    
Other Study ID Numbers: WZMC-2011-8
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Qichuan Zhuge, Wenzhou Medical University:
Chronic
Ischemic Stroke
Intracerebral Hemorrhage
Bone Marrow Mesenchymal Stem Cell
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases