SB623 is a proprietary, Cell Therapy Medicine (MSC implantation )made from modified and cultured adult bone marrow-derived mesenchymal stem cells that undergo temporary genetic modification. Implantation of SB623 cells into injured nerve tissue in the brain is expected to trigger the brain's natural regenerative ability to recover lost motor functions.
STEMTRA was a 12-month, Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to 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.
To be eligible for this trial, patients (ages 18-75) had to be at least 12 months post-TBI and had a Glasgow Outcome Scale extended (GOS-E) score of 3-6 (e.g., moderate or severe disability). Patients must also had to be able to undergo all planned neurological assessments and have had no seizures in the prior three months. The primary endpoint was mean change from baseline in Fugl-Meyer Motor Scale (FMMS) score which was used to measure changes in motor impairment at six months after treatment with SB623 cells. The STEMTRA trial enrolled 61 patients from 13 surgical and 18 assessment sites in the U.S., Japan and Ukraine.
In this study, SB623 met its primary endpoint, with patients treated with SB623 achieving an average 8.3 point improvement from baseline in the FMMS, versus 2.3 in the control group, at 24 weeks (p=0.040). Of patients treated with SB623, 18 (39.1%) reached a 10 or more point improvement of FMMS compared to one control patient (6.7%; p=0.039). No new safety signals were identified. The most commonly reported adverse event were headaches.
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2025/2/12
Publication of Results of Cell Implantation Location Analysis from Phase 2 Clinical Trial of Vandefitemcel (SB623) in TBI Patients (STEMTRA Trial) in Neurotrau2025/1/7
Publication of an Article in Molecular Therapy Demonstrates That the Human Bone Marrow-Derived Modified Mesenchymal Stem Cell Vandefitemcel (SB623) Improves Cortical Excitability in Rats with Focal Cerebral Ischemia2024/9/5
Positive Results of Key Development Product SB623 for Chronic Effects of Traumatic Brain Injury, including Sustained Motor Function Improvement up to 48 weeks, published in Neurology2024/7/10
[Results of Basic Research] Publication of an Article on the Neuronal Activity and Network Formation Promotion of the Key Development Product SB6232022/4/5
SB623 Demonstrated Sustained Improvement in Motor Impairment up to 48 Weeks and Associated with Improvement in Function and Activities of Daily Living in Patients with Chronic Traumatic Brain Injury2021/11/1
Publication Comparing Outcome Measures for Persons with Chronic Traumatic Brain Injury in Expert Review of Neurotherapeutics2021/3/1
Presentation of STEMTRA Phase 2 Trial Results at the 44th Annual Meeting of the Japan Society of Neurotraumatology2021/1/5
Publication of STEMTRA Phase 2 Interim Analysis for SB623 in Neurology®2020/9/14
Additional analytical results of the US-based Phase 2b clinical trial of regenerative cell medicine SB623 for the treatment of chronic motor deficit from ischemic stroke, and review of plans to initiate clinical trials for the ischemic stroke and hemorrhagic stroke programs in Japan based on these results