A Study of Modified Stem Cells in Stable Ischemic Stroke

Trial ID or NCT#

NCT01287936

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
View All Criteria
Show Less

Investigator(s)

Gary K. Steinberg, MD, PhD
Gary K. Steinberg, MD, PhD
Cerebrovascular neurosurgeon, Moyamoya surgeon, Aneurysm neurosurgeon, Neurosurgeon, Neurosurgeon
Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and Neurosciences and Professor, by courtesy, of Neurology

Contact us to find out if this trial is right for you.

Contact

Maria Coburn
650-736-9551

View on ClinicalTrials.gov