A Phase I/IIa Clinical Trial of a Recombinant Rho Protein Antagonist in Acute Spinal Cord Injury

作者: Michael G. Fehlings , Nicholas Theodore , James Harrop , Gilles Maurais , Charles Kuntz

DOI: 10.1089/NEU.2011.1765

关键词:

摘要: Abstract Multiple lines of evidence have validated the Rho pathway as important in controlling neuronal response to growth inhibitory proteins after central nervous system (CNS) injury. A drug called BA-210 (trademarked Cethrin®) blocks activation and has shown promise pre-clinical animal studies being used treat spinal cord injury (SCI). This is a report Phase I/IIa clinical study designed test safety tolerability drug, neurological status patients following administration single dose applied during surgery acute SCI. Patients with thoracic (T2-T12) or cervical (C4-T1) SCI were sequentially recruited for this dose-ranging (0.3 mg 9 mg Cethrin), multi-center 48 complete American Spinal Injury Association assessment (ASIA) A. Vital signs; laboratory tests; computed tomography (CT) scans spine, head, abdomen; magnetic resonance imaging (MRI) ASIA we...

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