Journal of neurotrauma
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Journal of neurotrauma · Mar 2019
Randomized Controlled Trial Multicenter StudyClinical Outcomes from a Multi-Center Study of Human Neural Stem Cell Transplantation in Chronic Cervical Spinal Cord Injury.
Human neural stem cell transplantation (HuCNS-SC®) is a promising central nervous system (CNS) tissue repair strategy in patients with stable neurological deficits from chronic spinal cord injury (SCI). These immature human neural cells have been demonstrated to survive when transplanted in vivo, extend neural processes, form synaptic contacts, and improve functional outcomes after experimental SCI. A phase II single blind, randomized proof-of-concept study of the safety and efficacy of HuCNS-SC transplantation into the cervical spinal cord was undertaken in patients with chronic C5-7 tetraplegia, 4-24 months post-injury. ⋯ At 1 year post-transplantation, there was no evidence of additional spinal cord damage, new lesions, or syrinx formation on magnetic resonance (MR) imaging. In summary, the incremental dose escalation design established surgical safety, tolerability, and feasibility in Cohort I. Interim analysis of Cohorts I and II demonstrated a trend toward Upper Extremity Motor Score (UEMS) and Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) motor gains in the treated participants, but at a magnitude below the required clinical efficacy threshold set by the sponsor to support further development resulting in early study termination.
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Journal of neurotrauma · Mar 2019
Multicenter StudyPredicting Psychological Distress after Pediatric Concussion.
A significant proportion of children and adolescents report psychological distress following concussion, but little is known about the predictors of these problems. The purpose of this study was to examine predictive factors of psychological distress following pediatric concussion. It was hypothesized that the presence of pre-injury psychological distress would be the strongest predictor of psychological distress post-concussion, with other demographic and acute injury factors adding incrementally to prediction. ⋯ A pre-injury diagnosis of anxiety and acutely forgetting recent information were significant predictors of psychological distress at 4 weeks, whereas worse acute orientation assessment in the ED predicted psychological distress at 12 weeks. Nearly one of four youth experienced psychological distress after concussion. Clinicians in acute care settings should screen for the factors (pre-injury anxiety, acute mental status) associated with post-injury psychological distress and consider proactively referring patients for further assistance.