A Study of Modified Stem Cells in Stable Ischemic Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SanBio, Inc.
ClinicalTrials.gov Identifier:
NCT01287936
First received: January 27, 2011
Last updated: August 30, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Chronic Ischemic Stroke
Biological: SB623
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by SanBio, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    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:
  • Improvement in stroke symptoms and brain metabolism [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 18
Study Start Date: January 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287936

Locations
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
Principal Investigator: Gary K Steinberg, M.D., Ph.D. Stanford University
Principal Investigator: Lawrence R Wechsler, M.D. University of Pittsburgh
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

No publications provided

Responsible Party: SanBio, Inc.
ClinicalTrials.gov Identifier: NCT01287936     History of Changes
Other Study ID Numbers: SB-STR01
Study First Received: January 27, 2011
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2014