Title
A Study of Modified Stem Cells in Stable Ischemic Stroke
A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke
Phase
Phase 1/Phase 2Lead Sponsor
SanBio, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Chronic Ischemic StrokeIntervention/Treatment
sb623 ...Study Participants
18The 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.
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.
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.
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
