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A Study of Modified Stem Cells in Stable Ischemic Stroke
This study has been completed.
Sponsor:
SanBio, Inc.
Information provided by (Responsible Party):
SanBio, Inc.
ClinicalTrials.gov Identifier:
NCT01287936
First received: January 27, 2011
Last updated: December 19, 2016
Last verified: November 2015
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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: | 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 ]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 ]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.
| Enrollment: | 18 |
| Study Start Date: | January 2011 |
| Study Completion Date: | August 2015 |
| 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) |
| Sexes Eligible for Study: | All |
| 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
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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
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | December 19, 2016 |
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 July 25, 2017