February 23, 2021; 96 (8) ArticleOpen Access
Cell Therapy for Chronic TBI
Interim Analysis of the Randomized Controlled STEMTRA Trial
View ORCID ProfileMasahito Kawabori, Alan H. Weintraub, Hideaki Imai, Iaroslav Zinkevych, Peter McAllister, Gary K. Steinberg, Benjamin M. Frishberg, Takao Yasuhara, Jefferson W. Chen, Steven C. Cramer, Achal S. Achrol, Neil E. Schwartz, Jun Suenaga, Daniel C. Lu, Ihor Semeniv, Hajime Nakamura, Douglas Kondziolka, Dai Chida, Takehiko Kaneko, Yasuaki Karasawa, Susan Paadre, Bijan Nejadnik, Damien Bates, Anthony H. Stonehouse, View ORCID ProfileR. Mark Richardson, David O. Okonkwo
First published January 4, 2021, DOI: https://doi.org/10.1212/WNL.0000000000011450
Masahito Kawabori
From 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.
Alan H. Weintraub
From 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.
Hideaki Imai
From 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.
Iaroslav Zinkevych
From 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.
Peter McAllister
From 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.
Gary K. Steinberg
From 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.
Benjamin M. Frishberg
From 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.
Takao Yasuhara
From 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.
Jefferson W. Chen
From 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.
Steven C. Cramer
From 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.
Achal S. Achrol
From 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.
Neil E. Schwartz
From 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.
Jun Suenaga
From 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.
Daniel C. Lu
From 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.
Ihor Semeniv
From 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.
Hajime Nakamura
From 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.
Douglas Kondziolka
From 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.
Dai Chida
From 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.
Takehiko Kaneko
From 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.
Yasuaki Karasawa
From 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.
Susan Paadre
From 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.
Bijan Nejadnik
From 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.
Damien Bates
From 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.
Anthony H. Stonehouse
From 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.
R. Mark Richardson
From 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.
David O. Okonkwo
From 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.
Cell Therapy for Chronic TBI
Interim Analysis of the Randomized Controlled STEMTRA Trial
Masahito Kawabori, Alan H. Weintraub, Hideaki Imai, Iaroslav Zinkevych, Peter McAllister, Gary K. Steinberg, Benjamin M. Frishberg, Takao Yasuhara, Jefferson W. Chen, Steven C. Cramer, Achal S. Achrol, Neil E. Schwartz, Jun Suenaga, Daniel C. Lu, Ihor Semeniv, Hajime Nakamura, Douglas Kondziolka, Dai Chida, Takehiko Kaneko, Yasuaki Karasawa, Susan Paadre, Bijan Nejadnik, Damien Bates, Anthony H. Stonehouse, R. Mark Richardson, David O. Okonkwo
Neurology Feb 2021, 96 (8) e1202-e1214; DOI: 10.1212/WNL.0000000000011450
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Abstract
Objective To determine whether chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by implantation of allogeneic modified bone marrow–derived mesenchymal stromal/stem cells (SB623).
Methods This 6-month interim analysis of the 1-year double-blind, randomized, surgical sham–controlled, phase 2 Stem Cell Therapy for Traumatic Brain Injury (STEMTRA) trial (NCT02416492) evaluated safety and efficacy of the stereotactic intracranial implantation of SB623 in patients with stable chronic motor deficits secondary to TBI. Patients in this multicenter trial (n = 63) underwent randomization in a 1:1:1:1 ratio to 2.5 × 106, 5.0 × 106, or 10 × 106 SB623 cells or control. Safety was assessed in patients who underwent surgery (n = 61), and efficacy was assessed in the modified intent-to-treat population of randomized patients who underwent surgery (n = 61; SB623 = 46, control = 15).
Results The primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale score at 6 months for SB623-treated patients was achieved. SB623-treated patients improved by (least square [LS] mean) 8.3 (standard error 1.4) vs 2.3 (standard error 2.5) for control at 6 months, the LS mean difference was 6.0 (95% confidence interval 0.3–11.8, p = 0.040). Secondary efficacy endpoints improved from baseline but were not statistically significant vs control at 6 months. There were no dose-limiting toxicities or deaths, and 100% of SB623-treated patients experienced treatment-emergent adverse events vs 93.3% of control patients (p = 0.25).
Conclusions SB623 cell implantation appeared to be safe and well tolerated, and patients implanted with SB623 experienced significant improvement from baseline motor status at 6 months compared to controls.
ClinicalTrials.gov Identifier: NCT02416492.
Classification of Evidence This study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.
Glossary
- ARAT=
- Action Research Arm Test;
- BDNF=
- brain-derived neurotrophic factor;
- CI=
- confidence interval;
- DRS=
- Disability Rating Scale;
- FMMS=
- Fugl-Meyer Motor Scale;
- GOS-E=
- Glasgow Outcome Scale–Extended;
- GV=
- gait velocity;
- ITT=
- intent-to-treat;
- LS=
- least square;
- mITT=
- modified ITT;
- MMRM=
- mixed-model repeated measures;
- MSC=
- mesenchymal stromal/stem cell;
- SE=
- standard error;
- STEMTRA=
- Stem Cell Therapy for Traumatic Brain Injury;
- TBI=
- traumatic brain injury;
- TEAE=
- treatment-emergent adverse event;
- TESAE=
- treatment-emergent serious adverse event
Footnotes
Go to Neurology.org/Nhttps://n.neurology.org/lookup/doi/10.1212/WNL.0000000000011450 for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
The Article Processing Charge was funded by SanBio, Inc.
Editorial, page 357
Class of Evidence: NPub.org/coe
CME Course: NPub.org/cmelist
- Received February 9, 2020.
- Accepted in final form October 20, 2020.
- Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
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Disputes & Debates: Rapid online correspondence
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