Cell Therapy for Chronic TBI Interim Analysis of the Randomized Controlled STEMTRA Trial

Kawabori, Masahito; Weintraub, Alan H.; Imai, Hideaki et al.

Neurology, 2021, 96(8), E1202-E1214

Permalink : https://hdl.handle.net/2115/82233

このアイテムのアクセス数:718件（2026-11-01 00:42 集計）

閲覧可能ファイル 

ファイル フォーマット サイズ 閲覧回数 説明
https://doi.org/10.1212/WNL.0000000000011450     78

論文情報

ファイル出力 EndNote Basic出力 Mendeley出力

アクセス権
open access
URI
https://hdl.handle.net/2115/82233
タイトル
Cell Therapy for Chronic TBI Interim Analysis of the Randomized Controlled STEMTRA Trial
著者
Kawabori, Masahito ; Weintraub, Alan H. ; Imai, Hideaki ; Zinkevych, Iaroslav ; McAllister, Peter ; Steinberg, Gary K. ; Frishberg, Benjamin M. ; Yasuhara, Takao ; Chen, Jefferson W. ; Cramer, Steven C. ; Achrol, Achal S. ; Schwartz, Neil E. ; Suenaga, Jun ; Lu, Daniel C. ; Semeniv, Ihor ; Nakamura, Hajime ; Kondziolka, Douglas ; Chida, Dai ; Kaneko, Takehiko ; Karasawa, Yasuaki ; Paadre, Susan ; Nejadnik, Bijan ; Bates, Damien ; Stonehouse, Anthony H. ; Richardson, R. Mark ; Okonkwo, David O.
e-Rad_Researcher
50399870
著者名
Kawabori, Masahito
著者名
Weintraub, Alan H.
著者名
Imai, Hideaki
著者名
Zinkevych, Iaroslav
著者名
McAllister, Peter
著者名
Steinberg, Gary K.
著者名
Frishberg, Benjamin M.
著者名
Yasuhara, Takao
著者名
Chen, Jefferson W.
著者名
Cramer, Steven C.
著者名
Achrol, Achal S.
著者名
Schwartz, Neil E.
著者名
Suenaga, Jun
著者名
Lu, Daniel C.
著者名
Semeniv, Ihor
著者名
Nakamura, Hajime
著者名
Kondziolka, Douglas
著者名
Chida, Dai
著者名
Kaneko, Takehiko
著者名
Karasawa, Yasuaki
著者名
Paadre, Susan
著者名
Nejadnik, Bijan
著者名
Bates, Damien
著者名
Stonehouse, Anthony H.
著者名
Richardson, R. Mark
著者名
Okonkwo, David O.
言語
英語
発行日
2021-02-23
出版者
Lippincott Williams & Wilkins (LWW)
収録物名
Neurology
巻(号)
96(8)
ページ
E1202-E1214
抄録
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 x 10(6), 5.0 x 10(6), or 10 x 10(6) 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 6months, 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. Classification of Evidence This study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.
資源タイプ
学術雑誌論文
出版タイプ
Version of Record
PISSN
0028-3878
関連情報 (isIdenticalTo)
出版社版DOI
https://doi.org/10.1212/WNL.0000000000011450