SanBio, Inc., has announced the randomization of the first patient in their STEMTRA Phase 2 clinical trial study for traumatic brain injury. The STEMTRA trial is presently enrolling patients in both the United States and Japan, and the first patient was randomized at Emory University Hospital in Atlanta, Ga.
STEMTRA stands for “Stem cell therapy for traumatic brain injury,” and this trial will examine the effects of SB623 stem cells to treat patients with chronic motor deficits that result from traumatic brain injury (TBI).
SB623, a proprietary product of SanBio, are bone marrow-derived mesenchymal stem cells that have been genetically engineered to express the intracellular domain of Notch-1. When injected into neural tissue, SB623 cells seem to reverse neural damage. Since SB623 cells come from donors, a single donor’s cells can be used to treat thousands of patients. In cell culture and animal models, SB623 cells restore function to neurons damaged by strokes, spinal cord injury and Parkinson’s disease. There have been no serious adverse events attributable to the cell therapy product and patients benefit on all three stroke scales.
Traumatic brain injuries (TBIs) can be caused by a wide range of events, including falls, fights, car accidents, gunshot wounds to the head, blows to the head from falling objects, and battlefield injuries. These events often result in permanent damage, including significant motor deficits; leaving more than 5.3 million people living with disabilities in the United States alone.
Damien Bates of SanBio, said, “This modified stem cell treatment has improved outcomes in patients with persistent limb weakness secondary to ischemic stroke. Our preclinical data suggest it may also help TBI patients. For people suffering from the often debilitating effects of TBI, this milestone brings us one step closer to proving whether it’s an effective treatment option.”
The STEMTRA trial follows a Phase 1/2a clinical trial in patients afflicted with chronic motor deficit secondary as a result of an ischemic stroke were treated with SB623 cells. In this trial, SB623 cells statistically significantly improved motor function following implantation. The STEMTRA study will evaluate the tolerability, efficacy, and safety of the SB623 cell treatment and the administration process in those patients who have suffered a TBI. As a Phase 2 trial, STEMTRA will evaluate the clinical efficacy and safety of intracranial administration of SB623 cells in patients with chronic motor deficit from TBI.
STEMTRA will be conducted across approximately 25 clinical trial sites throughout the United States and five sites in Japan. Total enrollment is expected to reach 52 patients in total, and all enrolled patients must have suffered their TBI at least 12 months ago.