Phase 1/2A Clinical Trial for Stroke Disability
Stroke is the leading cause of disability in the developed world, and up to 30% of stroke survivors have a permanent disability. Ample preclinical evidence reveals that SB623 cells (modified adult bone marrow-derived cells) are both safe and effective in restoring function following experimental chronic stroke.
SanBio is currently testing the SB623 cell therapy in a Phase 1/2A clinical trial that will enroll a total of 18 patients that are between 6 months and 5 years following ischemic stroke and have persistent disability. Three doses will be evaluated in an open-label, staggered escalation paradigm. Patients will be followed for two years to monitor safety of the SB623 cell therapy. While safety is the primary outcome measure, tests to assess motor, sensory, and cognitive ability will also be performed.
The trial is being conducted in Atlanta, Georgia, Birmingham, Alabama, Chicago, Illinois, Palo Alto, California and Pittsburgh, Pennsylvania.
All transportation and study-related costs will be covered.
Additional information about our FDA-approved clinical trial may be found at the US National Institutes of Health Clinical Trials website.
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Learn about SB623...
When injected into neural tissue, SB623 reverses neural damage. Since SB623 cells are allogeneic, a single donor's cells can be used to treat thousands of patients. In cell culture and animal models, SB623 cells have been shown to restore function to damaged neurons associated with stroke, spinal cord injury and Parkinson's disease. The Company believes SB623 may also be useful in other diseases and conditions associated with neurological deficit, such as traumatic brain injury, Huntington's disease and amyotrophic lateral sclerosis. SB623 cells function by promoting the body's natural regenerative process. SB623 is in the early clinical stage of development for stroke.