Interim Analysis of the STEMTRA Trial: Safety and Dose-Dependent Benefit in Traumatic Brain Injury Patients

Applying hiPSCs and Biomaterials Towards an Understanding and Treatment of Traumatic Brain Injury

“…Beyond animal work, six clinical trials have been completed to date, all using bone marrow-derived SCs except one, which used umbilical cord-derived SCs (Cox et al, 2011(Cox et al, , 2017Tian et al, 2013;Wang et al, 2013b;Liao et al, 2015;Cramer et al, 2019). In the most recent trial, lead by Cramer et al (2019), 61 chronic TBI patients were randomized into stem cell treated groups [receiving three different doses of allogeneic modified bone marrow-derived mesenchymal SCs (SB623)] by intracranial injection or surgical sham. The study showed no dose-limiting toxicities or deaths in treated groups and a statistically significant improvement in the Fugl-Meyer Motor Scale score at 24 weeks post-treatment, and the group treated with the highest dose (5.0 × 106 SB623) was the one showing the greatest benefits in motor status.…”