- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287936
A Study of Modified Stem Cells in Stable Ischemic Stroke
December 19, 2016 updated by: SanBio, Inc.
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.
Study Overview
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
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294-3410
- University of Alabama
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SB623
Administration of modified stem cells, SB623
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: Two years
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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
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Two years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in stroke symptoms and brain metabolism
Time Frame: Two Years
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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.
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Two Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Steinberg GK, Kondziolka D, Wechsler LR, Lunsford LD, Kim AS, Johnson JN, Bates D, Poggio G, Case C, McGrogan M, Yankee EW, Schwartz NE. Two-year safety and clinical outcomes in chronic ischemic stroke patients after implantation of modified bone marrow-derived mesenchymal stem cells (SB623): a phase 1/2a study. J Neurosurg. 2018 Nov 23:1-11. doi: 10.3171/2018.5.JNS173147. Online ahead of print.
- Steinberg GK, Kondziolka D, Wechsler LR, Lunsford LD, Coburn ML, Billigen JB, Kim AS, Johnson JN, Bates D, King B, Case C, McGrogan M, Yankee EW, Schwartz NE. Clinical Outcomes of Transplanted Modified Bone Marrow-Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study. Stroke. 2016 Jul;47(7):1817-24. doi: 10.1161/STROKEAHA.116.012995. Epub 2016 Jun 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
January 27, 2011
First Submitted That Met QC Criteria
January 31, 2011
First Posted (Estimate)
February 2, 2011
Study Record Updates
Last Update Posted (Estimate)
December 21, 2016
Last Update Submitted That Met QC Criteria
December 19, 2016
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SB-STR01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Ischemic Stroke
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
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University of WashingtonRecruitingStroke, Ischemic | Chronic StrokeUnited States
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Suzhou Neuralstem BiopharmaceuticalsUnknownIschemic Motor Stroke, ChronicChina
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Icahn School of Medicine at Mount SinaiRecruitingChronic Ischemic StrokeUnited States
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MedStar National Rehabilitation NetworkEnrolling by invitationStroke, Ischemic | Chronic Stroke | Ambulation Disorder, NeurologicUnited States
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Hopstem Biotechnology Inc.Recruiting
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SanBio, Inc.SunovionCompletedChronic Ischemic StrokeUnited States
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Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
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University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
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Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
Clinical Trials on SB623
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SanBio, Inc.SunovionCompletedChronic Ischemic StrokeUnited States
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SanBio, Inc.CompletedTraumatic Brain InjuryUnited States, Japan, Ukraine