This trial is active, not recruiting.

Condition chronic ischemic stroke
Treatment sb623
Phase phase 1/phase 2
Sponsor SanBio, Inc.
Start date January 2011
End date August 2015
Trial size 18 participants
Trial identifier NCT01287936, SB-STR01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Administration of modified stem cells, 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.

Primary Outcomes

time frame: Two years

Secondary Outcomes

Improvement in stroke symptoms and brain metabolism
time frame: Two Years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke
Principal investigator Gary K Steinberg, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by SanBio, Inc..