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

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Title: Cell Therapy for Chronic TBI Interim Analysis of the Randomized Controlled STEMTRA Trial
Authors: Kawabori, Masahito Browse this author →KAKEN DB
Weintraub, Alan H. Browse this author
Imai, Hideaki Browse this author
Zinkevych, Iaroslav Browse this author
McAllister, Peter Browse this author
Steinberg, Gary K. Browse this author
Frishberg, Benjamin M. Browse this author
Yasuhara, Takao Browse this author
Chen, Jefferson W. Browse this author
Cramer, Steven C. Browse this author
Achrol, Achal S. Browse this author
Schwartz, Neil E. Browse this author
Suenaga, Jun Browse this author
Lu, Daniel C. Browse this author
Semeniv, Ihor Browse this author
Nakamura, Hajime Browse this author
Kondziolka, Douglas Browse this author
Chida, Dai Browse this author
Kaneko, Takehiko Browse this author
Karasawa, Yasuaki Browse this author
Paadre, Susan Browse this author
Nejadnik, Bijan Browse this author
Bates, Damien Browse this author
Stonehouse, Anthony H. Browse this author
Richardson, R. Mark Browse this author
Okonkwo, David O. Browse this author
Issue Date: 23-Feb-2021
Publisher: Lippincott Williams & Wilkins (LWW)
Journal Title: Neurology
Volume: 96
Issue: 8
Start Page: E1202
End Page: E1214
Publisher DOI: 10.1212/WNL.0000000000011450
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 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.
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

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