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New Brain Cell Trial Opened for Stroke Repair

SB623
SB623 brain cell

Pittsburgh, August 5, 2011 -- The University of Pittsburgh departments of Neurological Surgery and Neurology have opened a new clinical study to evaluate the safety and tolerability of intracranial administration of brain cells for the care of patients with stroke. Douglas Kondziolka, MD, professor of neurological surgery and director of UPMC’s Center for Brain Function & Behavior, and Lawrence Wechsler, MD, professor and chair of UPMC’s Department of Neurology are the lead investigators for the study.

The brain cells, known as SB623 cells, are adult bone-marrow-derived cells that have been transiently transfected with a plasmid construct encoding the intracellular domain of human Notch-1 (a gene involved in differentiation). SB623 cells secrete factors that protect neurons in models of ischemic insult.  In a rat occlusion model of stroke to the middle cerebral artery region, implantation of SB623 into and around the area of the infarct resulted in improvement of neurological behavior.

The safety of implanted SB623 cells was evaluated in a six-month primate study and in two nude rat studies (four months and twelve months). The primates were immunosuppressed with cyclosporine and the nude rats further immunosuppressed with an anti-NK cell antibody.  There were no SB623-related clinical, laboratory, or histological abnormalities found.

The stereotactic surgical delivery of cells to patients with stroke has been shown to have an acceptable safety profile in two prior clinical studies with another product. In addition, a retrospective study of over 2,650 patients undergoing stereotactic surgery during a 28-year period at one major clinic has shown a high degree of safety of the procedure.

Finally, use of the European Stroke Scale (ESS), the Modified Rankin Score, the National Institute of Health Stroke Scale (NIHSS), the Fugl-Meyer scale for motor function, and a neurocognitive battery (e.g., Rey Complex Figure Test), have been used and validated, at least for acute stroke. Fluorodeoxyglucose positron emission tomography (FDG-PET) imaging has shown that changes in metabolic activity relative to baseline in the infarct area and surrounding areas correlated with performance on the motor subscale of the ESS.

For inclusion in the study, participants must have experienced an ischemic stroke in the subcortical region of MCA or lenticulostriate artery with or without cortical involvement six to twelve months post-stroke and must be stable for at least three weeks. Participants must have a modified Rankin Score 3 or 4 and a NIHSS Score >7.

For more information on the study, please contact Julia Billigen, study coordinator at (412) 605-3959 or billigenjb@upmc.edu.