Neuroprotective therapy with granulocyte colony-stimulating factor in acute spinal cord injury: a comparison with high-dose methylprednisolone as a historical control.

ABSTRACT

PURPOSE: We performed a phase I/IIa clinical trial and confirmed the safety and feasibility of granulocyte colony-stimulating factor (G-CSF) as neuroprotective therapy in patients with acute spinal cord injury (SCI). In this study, we retrospectively analyzed the clinical outcome in SCI patients treated with G-CSF and compared these results to a historical cohort of SCI patients treated with high-dose methylprednisolone sodium succinate (MPSS). METHODS: In the G-CSF group (n = 28), patients were treated from August 2009 to July 2012 within 48 h of the injury, and G-CSF (10 µg/kg/day) was administered intravenously for five consecutive days. In the MPSS group (n = 34), patients underwent high-dose MPSS therapy from August 2003 to July 2005 following the NASCIS II protocol. We evaluated the ASIA motor score and the AIS grade elevation between the time of treatment and 3-month follow-up and adverse events. RESULTS: The ΔASIA motor score was significantly higher in the G-CSF group than in the MPSS group (p < 0.01). When we compared AIS grade elevation in patients with AIS grades B/C incomplete paralysis, 17.9% of patients in the G-CSF group had an AIS grade elevation of two steps compared to 0% of patients in the MPSS group (p < 0.05), and the incidence of pneumonia was significantly higher in the MPSS group (42.9%) compared to the G-CSF group (8.3%) (p < 0.05). CONCLUSIONS: These results suggest that G-CSF administration is safe and effective, but a prospective randomized controlled clinical trial is needed to compare the efficacy of MPSS versus G-CSF treatment in patients with SCI.