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

January 27, 2011
August 30, 2013
January 2011
May 2015   (final data collection date for primary outcome measure)
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
Safety [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Safety will be evaluated using the WHO safety criteria and by periodic MRIs
Complete list of historical versions of study NCT01287936 on ClinicalTrials.gov Archive Site
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.
Improvement in stroke symptoms and brain metabolism [ Time Frame: 6-24 months ] [ Designated as safety issue: No ]
Possible improvement in stroke symptoms will be deterimed 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.
Not Provided
Not Provided
 
A Study of Modified Stem Cells in Stable Ischemic Stroke
A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Ischemic Stroke
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.
Experimental: SB623
Administration of modified stem cells, SB623
Intervention: Biological: SB623
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01287936
SB-STR01
Yes
SanBio, Inc.
SanBio, Inc.
Not Provided
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
SanBio, Inc.
May 2013

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