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A Study of Modified Stem Cells in Stable Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01287936
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
SanBio, Inc.

Study Description
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Brief Summary:
The primary purpose of the clinical study is to determine the safety of a modified stem cell SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke patients must be between 6 and 60 months after their stroke, and with only this one prior stroke, and and with no further improvement from physical therapy.

Condition or disease Intervention/treatment Phase
Chronic Ischemic Stroke Biological: SB623 Phase 1 Phase 2

Detailed Description:
Chronic, stable stroke patients have no existing alternative treatments after rehabilitation therapy. SB623, a modified stem cell preparation, has been shown to improve motor function when administered in animal models of stable stroke. Safety studies in animals have shown no adverse events attributed to SB623. Patients who meet the entry criteria for this study will have regular examinations, radiological evaluations (CT, MRI, PET), and be followed for two years. Regular neurological evaluations will also be done using standard questionnaires, with occasional video recording if improvements are evident. Key entry criteria for this study, in addition to 6-60 months post-ischemic stroke, include moderately severe symptoms--e.g., difficulty standing or walking, and/or difficulty using arms or hands, and/or speech impediments.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke
Study Start Date : January 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: SB623
Administration of modified stem cells, SB623
 Biological: SB623
SB623, a modified stem-cell product, will be administered at 3 dose levels. Each patient in one of three groups will be given a dose of 2.5, 5.0, or 10 million cells once. Each group will be completed before going to the next higher-dose group.


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: Two years ]
    Safety will be evaluated using the WHO safety criteria, by periodic MRIs, frequent laboratory monitoring, and by periodic measurements of possible humoral and cell-mediated immunological changes


Secondary Outcome Measures :
  1. Improvement in stroke symptoms and brain metabolism [ Time Frame: Two Years ]
    Possible improvement in stroke symptoms will be determined by a variety of neurological assessments: European Stroke Scale, NIH Stroke Scale, Modified Rankin Score, and Fugl-Meyer assessment. Possible improvement in brain metabolism will be assessed using FDG-PET scans.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented history of one completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement
  • Between 6 and 60 months post-stroke, and having a motor neurological deficit
  • No significant further improvement with physical therapy/rehabilitation
  • Able and willing to undergo computed tomography (CT), magnetic resonance imaging (MRI), and positron-emission tomography (PET) scans of the head

Exclusion Criteria:

  • History of more than 1 symptomatic stroke
  • History of seizures
  • History or presence of any other major neurological disease
  • Myocardial infarction within prior 6 mos.
  • Known presence of any malignancy except squamous or basal cell carcinoma of the skin
  • Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
  • Contraindications to head CT, MRI, or PET
  • Pregnant or lactating
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): NCT01287936


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294-3410
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
SanBio, Inc.
Investigators
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Principal Investigator: Gary K Steinberg, M.D., Ph.D. Stanford University
Principal Investigator: Lawrence R Wechsler, M.D. University of Pittsburgh Medical Center
Principal Investigator: Joshua M Rosenow, M.D. ,FACS Northwestern University Feinberg School of Medicine
Principal Investigator: James Markert, M.D. University of Alabama at Birmingham
Principal Investigator: Robert E Gross, M.D., Ph.D. Emory University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SanBio, Inc.
ClinicalTrials.gov Identifier: NCT01287936     History of Changes
Other Study ID Numbers: SB-STR01
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: November 2015

Keywords provided by SanBio, Inc.:
Chronic Stroke
Stable Stroke

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia