Neurology, University of California, Los Angeles, 6Stanford Stroke Center, 7Department of Neurosurgery, Hokkaido University Hospital, 8Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, 9SanBio, Inc., 10JCHO Tokyo Shinjuku Medical Center, 11Craig Hospital, Rocky Mountain Regional Brain Injury System
Objective:
To determine if chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by intracranial implantation of SB623 cells.
Background:
TBI often causes chronic disability associated with motor deficits for which no effective pharmacological treatments are available.
Design/Methods:
This analysis of the completed 48-week double-blind, randomized, surgical sham-controlled, Phase 2 STEMTRA trial (NCT02416492), evaluated the safety and efficacy of stereotactic intracranial implantation of allogeneic modified bone marrow-derived mesenchymal stromal cells (SB623) in patients with stable chronic motor deficits secondary to TBI. Sixty-three patients underwent randomization in a 1:1:1:1 ratio to either 2.5x106, 5.0x106, 10x106 SB623 cells or surgical sham procedure. Safety and efficacy were assessed in patients who underwent surgery (N=61; SB623=46, sham controls=15).
Results:
The primary efficacy endpoint of significant change from baseline in the Fugl-Meyer Motor Scale score (FMMS) for SB623-treated patients compared to controls at 24 weeks was achieved (LS mean [SE]: +8.3 [1.4] SB623 versus +2.3 [2.5] control, P=0.04). At 48 weeks, FMMS, Action Research Arm Test, Gait Velocity, and NeuroQOL upper and lower extremity function T scores were significantly improved from baseline in SB623-treated patients, and were greater than controls, however, differences between SB623-treated and control patients were not statistically significant. At 48 weeks, all SB623-treated and control patients had experienced at least one treatment-emergent adverse eve
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Neurology, University of California, Los Angeles, 6Stanford Stroke Center, 7Department of Neurosurgery, Hokkaido University Hospital, 8Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, 9SanBio, Inc., 10JCHO Tokyo Shinjuku Medical Center, 11Craig Hospital, Rocky Mountain Regional Brain Injury System
Objective:
To determine if chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by intracranial implantation of SB623 cells.
Background:
TBI often causes chronic disability associated with motor deficits for which no effective pharmacological treatments are available.
Design/Methods:
This analysis of the completed 48-week double-blind, randomized, surgical sham-controlled, Phase 2 STEMTRA trial (NCT02416492), evaluated the safety and efficacy of stereotactic intracranial implantation of allogeneic modified bone marrow-derived mesenchymal stromal cells (SB623) in patients with stable chronic motor deficits secondary to TBI. Sixty-three patients underwent randomization in a 1:1:1:1 ratio to either 2.5x106, 5.0x106, 10x106 SB623 cells or surgical sham procedure. Safety and efficacy were assessed in patients who underwent surgery (N=61; SB623=46, sham controls=15).
Results:
The primary efficacy endpoint of significant change from baseline in the Fugl-Meyer Motor Scale score (FMMS) for SB623-treated patients compared to controls at 24 weeks was achieved (LS mean [SE]: +8.3 [1.4] SB623 versus +2.3 [2.5] control, P=0.04). At 48 weeks, FMMS, Action Research Arm Test, Gait Velocity, and NeuroQOL upper and lower extremity function T scores were significantly improved from baseline in SB623-treated patients, and were greater than controls, however, differences between SB623-treated and control patients were not statistically significant. At 48 weeks, all SB623-treated and control patients had experienced at least one treatment-emergent adverse eve