Safety of Granulocyte Colony-Stimulating Factor (G-CSF) Administration for Postrehabilitated Motor Complete Spinal Cord Injury Patients: An Open-Label, Phase I Study
Abstract:Granulocyte colony-stimulating factor (G-CSF) is a major growth factor in the activation and differentiation of granulocytes. This cytokine has been widely and safely employed in different conditions over many years. In this translational study, G-CSF is administered to 19 patients with chronic motor complete spinal cord injury, and outcomes are reported. All 19 patients received subcutaneous G-CSF (5 µg/kg per day) for 5 days and were followed for at least 6 months. The American Spinal Injury Association (ASIA) scale was used for motor and sensory assessment, and the International Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS) and the Spinal Cord Independence Measure (SCIM) III were used to assess improvements in the ability to perform basic daily tasks. At the 6-month follow-up, upper extremity motor scores improved by 10, which was statistically significant (p = 0.007), whereas there were no significant changes in lower extremity motor scores. Also, the median of light touch sensory scores improved by 5 (p = 0.001). Pinprick sensory scores significantly improved (p = 0.002). The median increment in SCIM III total score was 7 (p = 0.001). The improvements in bladder and bowel management as well as moderate distance mobility subscales were also significant (p < 0.05). Total IANR-SCIFRS scores changed from 17 to 32, which was statistically significant (p = 0.001); again the bladder and bowel management subscale improvements were statistically significant (p < 0.05). Mild side effects of the G-CSF treatment such as bone pain, rash, fever, neuropathic pain, and spasticity were noted in a few patients; all of them resolved after 1 week. Our results indicate that G-CSF administration is a safe process and is associated with neurological as well as functional improvement. This manuscript is published as part of the International Association of Neurorestoratology (IANR) supplement issue of Cell Transplantation.
Document Type: Research Article
Publication date: December 17, 2013
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