The SanBio Group has published the interim analysis data from its Phase II clinical STEM cell therapy for the TRAumatic brain injury (STEMTRA) trial of investigational product, SB623, to treat traumatic brain injury (TBI) patients. A cell-based product, SB623 is developed from allogeneic modified and cultured adult bone marrow-derived mesenchymal stem cells (MSCs) that go through temporary genetic modification.
Implanting SB623 cells into injured brain nerve tissue can potentially stimulate the brain’s natural regenerative ability to recuperate lost motor functions. The randomised, double-blind, surgical sham-controlled, global trial is analysing the efficacy and safety of SB623 versus sham surgery in patients with stable chronic neurological motor deficits secondary to TBI.
In this study, SB623 cells were implanted directly around the site of brain injury. Interim data from the study showed that the patients who received SB623 treatment significantly improved from the baseline of Fugl-Meyer Motor Scale (FMMS) score at six months, meeting the primary efficacy endpoint.