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A Study of Modified Stem Cells in Stable Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

Tracking Information
First Submitted Date  ICMJE January 27, 2011
First Posted Date  ICMJE February 2, 2011
Last Update Posted Date December 21, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2011)
Safety [ Time Frame: Two years ]
Safety will be evaluated using the WHO safety criteria and by periodic MRIs
Change History Complete list of historical versions of study NCT01287936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2011)
Improvement in stroke symptoms and brain metabolism [ Time Frame: 6-24 months ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Modified Stem Cells in Stable Ischemic Stroke
Official Title  ICMJE A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Ischemic Stroke
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: SB623
Administration of modified stem cells, SB623
Intervention: Biological: SB623
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2011)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01287936
Other Study ID Numbers  ICMJE SB-STR01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SanBio, Inc.
Study Sponsor  ICMJE SanBio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account SanBio, Inc.
Verification Date November 2015

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