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

Contact

Maria Coburn
650-736-9551

View on ClinicalTrials.gov