A Study of Modified Stem Cells in Stable Ischemic Stroke
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | June 2016 |
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.
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.
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.
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.
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
We found this trial at
5
sites
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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