McGowan Institute for Regenerative Medicine
affiliated faculty member Douglas Kondziolka, MD, MS, FRCS (C) (pictured), the Peter J. Jannetta Professor of Neurological Surgery and Radiation Oncology, the Vice Chairman, Education, the Director, Center for Brain Function & Behavior, and Co-Director, Center for Image-Guided Neurosurgery, University of Pittsburgh, is a principal investigator in the SB623 clinical trial, the only clinical trial currently open in the United States testing the regenerative potential of cell therapy in the brain. SanBio Inc. recently announced that the United States Food and Drug Administration had 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 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. Kondziolka. 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.
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. SanBio Inc. 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.
Illustration: McGowan Institute for Regenerative Medicine.
Bio: Dr. Douglas Kondziolka