Stem cell implants show promise in chronic traumatic brain injury

Autor: Laroslav Zinkevych, Dai Chida, Alan Weintraub, Yasuaki Karasawa, Bijan Nejadnik, Daniel C. Lu, Hajime Nakamura, David O. Okonkwo, Masahito Kawabori, Takehiko Kaneko, Neil E. Schwartz, Susan Paadre, Jefferson W. Chen, Achal S. Achrol, Benjamin M. Frishberg, Steven C. Cramer, Takao Yasuhara, Douglas Kondziolka, Jun Suenaga, Peter McAllister, Anthony H. Stonehouse, Gary K. Steinberg, Damien Bates, Ihor Semeniv, Hideaki Imai, R. Mark Richardson
Rok vydání: 2021
Předmět:
0301 basic medicine
Randomization
Physical Injury - Accidents and Adverse Effects
Traumatic brain injury
Population
Clinical Trials and Supportive Activities
Clinical Sciences
MEDLINE
Traumatic Brain Injury (TBI)
Bioinformatics
Mean difference
Article
Cell therapy
03 medical and health sciences
Cellular and Molecular Neuroscience
0302 clinical medicine
Injury - Trauma - (Head and Spine)
Clinical Research
Medicine
In patient
Adverse effect
education
Traumatic Head and Spine Injury
education.field_of_study
Neurology & Neurosurgery
business.industry
Neurosciences
Interim analysis
medicine.disease
Brain Disorders
030104 developmental biology
Anesthesia
Injury (total) Accidents/Adverse Effects
Cognitive Sciences
Neurology (clinical)
Patient Safety
Stem cell
Injury - Traumatic brain injury
business
030217 neurology & neurosurgery
Zdroj: Neurology
article-version (Version of Record) 3
Neurology, vol 96, iss 8
ISSN: 1759-4766
0241-6492
Popis: ObjectiveTo 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).MethodsThis 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).ResultsThe 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).ConclusionsSB623 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 EvidenceThis study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.
Databáze: OpenAIRE
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