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.
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Secondary efficacy endpoints were not statistically significant as compared to control. The SB623 treatment was observed to be safe and well-tolerated.
SanBio Group chief medical officer and research head Bijan Nejadnik said: “Publication of our STEMTRA data in Neurology further validates our efforts to raise awareness and improve the lives of patients suffering from the long-term complications of TBI.”
The STEMTRA trial was conducted at 27 sites across the US, Japan and Ukraine, and treated 61 patients, who were followed for up to 12 months.
Hokkaido University Hospital, Japan department of neurosurgery specially appointed associate professor and STEMTRA trial investigator Masahito Kawabori said: “We are encouraged by the positive data from the study in which the procedure and treatment were well-tolerated, and that patients implanted with SB623 experienced significant improvement in their motor status.
“Importantly, we believe publication of the STEMTRA interim results underscores the potential for cell therapy to improve the mobility for chronic TBI patients.”
In 2018, SanBio reported positive results from the Phase II STEMTRA trial after it met the primary endpoint.