CT scan showing cerebral contusions, haemorrhage within the hemispheres, subdural hematoma, and skull fractures. Credit: Delldot.

SanBio Group has reported positive results from the Phase II STEMTRA trial after it met the primary endpoint.

The STEMTRA trial evaluated SB623 cells for treatment of patients with traumatic brain injury (TBI).

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Results demonstrated that TBI patients with chronic motor deficits treated with SB623 cells achieved a statistically significant improvement in their motor function compared to the control group. Fugl-Meyer Motor Scale (FMMS) was used to measure this data.

At 24 weeks, patients receiving SB623 experienced an average improvement of 8.7 points from baseline in the FMMS, against 2.4 in the control group.

“This is a significant milestone for regenerative medicine and for many patients suffering from persistent disabilities caused by TBI.”

Analysis of the safety data also found that SB623 was well tolerated among patients. The trial did not report any new safety signals.

Based on these results, SanBio Group is expected to apply for marketing approval of SB623 in Japan by January 2020.

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SanBio Group chief medical officer and research head Damien Bates said: “This global clinical trial, the largest stem cell study ever conducted for TBI, is especially exciting given the rigor of its randomised double-blind design and demonstration of significant improvement in motor function for many patients treated with SB623 cells.

“This is a significant milestone for regenerative medicine and for many patients suffering from persistent disabilities caused by TBI.”

TBI is an injury to the brain caused by external damage to the head. It can lead to the development of physical, cognitive, social, emotional, and behavioural symptoms.