FDA approves clinical testing of SanBio's SB623 for stroke recovery

Jun 17 2010

SanBio Inc. (www.san-bio.com) announced today that the United States Food and Drug Administration (FDA) has approved the clinical testing of their SB623 regenerative medicine product in patients suffering from disability caused by cerebral stroke. SB623 is derived from bone marrow stromal cells (MSCs) isolated from healthy adult donors.

This Phase 1/2a clinical trial will test the safety of SB623 when implanted in the damaged regions of the brains of stable stroke patients. "We are pleased and proud to be given the opportunity to move this therapeutic approach forward. This is the only clinical trial currently open in the United States testing the regenerative potential of cell therapy in the brain," said Kieta Mori, co-CEO of SanBio. "This cell product has the potential to change the lives of patients afflicted by stroke injury," said Dr. Douglas Kondziolka, the Peter J. Jannetta Professor of Neurological Surgery in the Department of Neurological Surgery, Director, Center for Brain Function and Behavior at the University of Pittsburgh School of Medicine and a Principal Investigator in the SB623 clinical trial. According to the American Heart Association, stroke is the third leading cause of death in the United States and the leading cause of serious long-term disability. "Cell therapy has great potential in many degenerative diseases of the central nervous system. SB623's entry into human clinical testing marks an important step forward for the field," said Dr. Gary Steinberg, the Lacroute-Hearst Professor, Chairman of the Department of Neurosurgery, and Director of the Stanford Institute for Neuro-Innnovation and Translational Neurosciences at the Stanford University School of Medicine. Dr. Steinberg is also a Principal Investigator in the SB623 clinical trial.