Cell Therapy for Chronic TBI: Interim Analysis of the Randomized Controlled STEMTRA Trial
Masahito Kawabori1, Alan H Weintraub2, Hideaki Imai2
1From the Department of Neurosurgery (M.K.), Hokkaido University Hospital, Sapporo, Japan; Rocky Mountain Regional Brain Injury System and University of Colorado School of Medicine (A.H.W.), Englewood; JCHO Tokyo Shinjuku Medical Center (H.I.), Japan; Ukraine Presidential Hospital (I.Z.), Kiev; New England Institute for Neurology and Headache (P.M.); New England Institute for Clinical Research (P.M.), Stamford; Department of Neurology (P.M.), Yale University, New Haven; Frank Netter School of Medicine (P.M.), Quinnipiac University, Hamden, CT; Department of Neurosurgery (G.K.S.), Department of Neurology and Neurological Sciences (N.E.S.), and Stanford Stroke Center (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; The Neurology Center of Southern California (B.M.F.), Carlsbad; Department of Neurological Surgery (T.Y.), Okayama University Graduate School of Medicine, Okayama University Hospital, Japan; Department of Neurological Surgery (J.W.C.), University of California, Irvine, School of Medicine; Department of Neurology (S.C.C.), University of California, Los Angeles; California Rehabilitation Institute (S.C.C.); Los Angeles; Department of Neurosurgery (A.S.A.), Loma Linda University Medical Center; Department of Neurosurgery (J.S.), Yokohama City University School of Medicine, Kanagawa, Japan; Department of Neurosurgery (D.C.L.), Ronald Reagan UCLA Medical Center, Los Angeles, CA; Clinical Hospital Feofaniya (I.S.), Kiev, Ukraine; Department of Neurosurgery (H.N.), Osaka University Graduate School of Medicine, Suita, Japan; Department of Neurosurgery (D.K.), New York University and NYU Langone Medical Center, NY; SanBio, Inc (D.C., T.K., B.N., D.B.), Mountain View, CA; Department of Neurosurgery (Y.K.), University of Tokyo Hospital, Japan; Biostatistical Consulting Inc (S.P.), Lexington, MA; Watson & Stonehouse Enterprises LLC (A.H.S.), Pacific Grove, CA; Massachusetts General Hospital and Harvard Medical School (R.M.R.), Boston; and Department of Neurological Surgery (D.O.O.), University of Pittsburgh Medical Center, PA. kawabori@med.hokudai.ac.jp.
This study found that SB623 cell implantation improved motor function in patients with traumatic brain injury (TBI). The treatment was safe and well-tolerated, showing significant motor status improvement at six months compared to controls.
Area of Science:
- Neuroscience
- Regenerative Medicine
- Clinical Trials
Background:
- Chronic motor deficits are a common sequela of traumatic brain injury (TBI).
- Current treatments for TBI-related motor deficits have limited efficacy.
- Novel therapeutic strategies are needed to improve motor function after TBI.
Purpose of the Study:
- To evaluate the safety and efficacy of SB623 cell implantation for improving chronic motor deficits in TBI patients.
- To determine the optimal dose of SB623 cells for therapeutic benefit.
- To assess the long-term outcomes of SB623 cell therapy in TBI.
Main Methods:
- A 6-month interim analysis of a phase 2, double-blind, randomized, sham-controlled trial (STEMTRA) involving 63 TBI patients.
- Patients received stereotactic intracranial implantation of SB623 cells at three different doses or a sham procedure.
- Safety was assessed in 61 patients, and efficacy in 61 patients (46 SB623, 15 control).
Main Results:
- The primary efficacy endpoint, improvement in Fugl-Meyer Motor Scale score at 6 months, was significantly achieved in SB623-treated patients (8.3 points) versus controls (2.3 points).
- The least squares mean difference was 6.0 (95% CI 0.3-11.8, p=0.040).
- No dose-limiting toxicities or deaths occurred; treatment-emergent adverse events were comparable between groups.
Conclusions:
- SB623 cell implantation is safe and well-tolerated in TBI patients.
- SB623 therapy led to significant improvements in motor status at 6 months post-implantation compared to controls.
- These findings support SB623 as a promising therapeutic agent for TBI-related motor deficits.
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