©2024 Stanford Medicine
A Study of Modified Stem Cells in Stable Ischemic Stroke
Not Recruiting
Trial ID: NCT01287936
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 with no further improvement from physical therapy.
Official Title
A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke
Stanford Investigator(s)
Gary K. Steinberg, MD, PhD
Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and Neurosciences and Professor, by courtesy, of Neurology
Eligibility
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
Intervention(s):
biological: SB623
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Coburn
650-736-9551