A possible stem cell treatment for TBI patients demonstrated positive results in a recent phase 2 trial. 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).