A Study of Modified Stem Cells in Stable Ischemic Stroke
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ClinicalTrials.gov Identifier: NCT01287936 |
Recruitment Status :
Completed
First Posted : February 2, 2011
Last Update Posted : December 21, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Ischemic Stroke | Biological: SB623 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: SB623
Administration of modified stem cells, SB623
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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. |
- 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
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287936
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 |
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 |
Responsible Party: | SanBio, Inc. |
ClinicalTrials.gov Identifier: | NCT01287936 |
Other Study ID Numbers: |
SB-STR01 |
First Posted: | February 2, 2011 Key Record Dates |
Last Update Posted: | December 21, 2016 |
Last Verified: | November 2015 |
Chronic Stroke Stable Stroke |
Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |