A Study of Modified Stem Cells in Stable Ischemic Stroke - Full Text View

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:	June 2016
Primary Completion Date:	August 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 (Adult, Senior)
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


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:	November 16, 2015
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 Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia

ClinicalTrials.gov processed this record on September 23, 2016