Phase 2 trial results suggest the possibility of a treatment that may regenerate brain cells following TBI.
A possible stem cell treatment for patients with traumatic brain injury (TBI) demonstrated positive results in a recent phase 2 trial. The results were announced by the manufacturer of the investigational treatment, the SanBio Group, in a press release and were also presented at the American Association of Neurological Surgeons Annual Scientific Meeting in San Diego, California, April 13 to 17, 2019.1
The trial included 61 patients with stable chronic motor deficits caused by TBI: 46 were treated with the investigational stem cell product, SB623, and 15 underwent sham surgery as a control group. The SB623 cells were implanted directly around the site of brain injury.
Improvement was measured by the change from baseline in the Fugl-Meyer Motor Scale (FMMS) score. The scale measures changes in motor impairment, and a 10 or higher point improvement is considered a clinically meaningful threshold in acquired brain injury. Eighteen patients treated with SB623 (39.1%) reached this threshold compared with one control patient (6.7%). This difference was statistically significant (P = .044).
No new safety signals were identified. Post-operative headaches were the most common adverse events (42.6%). No significant differences were found in the rate of adverse events between patients treated with SB623 and those who received the placebo treatment (P = .25).
“The results of this study are truly groundbreaking, demonstrating the possibility of regenerating the brain following injury-a finding that could have significant implications for research in traumatic brain injury and other brain diseases,” said David O. Okonkwo, MD, PhD, Professor of Neurological Surgery and Director of the Neurotrauma Clinical Trials Center at the University of Pittsburgh, in a press statement.
For more information on stem cell therapy for other neurological disorders:
1. AANS 2019: SB623 demonstrated statistically significant improvement in motor function among patients with chronic motor deficit from traumatic brain injury (TBI) [press release]. Mountain View, CA: The SanBio Group; April 16, 2019.