The Stanford University School of Medicine and SanBio Inc. today announced the initiation of a Phase 1/2a clinical trial testing the safety and efficacy of a novel allogeneic cell therapy product, SB623, on patients suffering from stable deficits resulting from previous stroke injuries. For details regarding this clinical trial, please refer to the Clinicaltials.gov website http://www.clinicaltrials.gov/ct2/show/NCT01287936.
SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of stroke disability. "SB623 represents a significant step forward in the development of regenerative therapies for the treatment of brain injury," said Keita Mori, SanBio CEO. "We are pleased to initiate a first-in-man study of SB623."
SB623 will be administered by intracranial injection into the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy will also be tested.
"This is a completely new approach to therapy for stroke victims," said Dr. Gary Steinberg, the Lacroute-Hearst Professor, Chairman of the Department of Neurosurgery, and Director of the Stanford Institute for Neuro-Innovation and Translational Neurosciences at the Stanford University School of Medicine, and Principal Investigator of the study. Sub-Investigator Dr. Neil Schwartz, Clinical Assistant Professor of Neurology, Stanford Stroke Center, said, "If successful, this cell therapy offers hope to otherwise permanently disabled patients."
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