Neuroprotective therapy using granulocyte colony-stimulating factor for acute spinal cord injury: a phase I/IIa clinical trial

Abstract

These results indicate that intravenous administration of G-CSF (10 μg/kg/day) for 5 days is essentially safe, and suggest that some neurological recovery may occur in most patients. We suggest that G-CSF administration could be therapeutic for patients with acute SCI.

Granulocyte colony-stimulating factor attenuates spinal cord injury-induced mechanical allodynia in adult rats

“…Moreover, it was reported that G-CSF attenuates peripheral NeP [11,12]. We recently conducted early-phase clinical trials to prove neuroprotective effects of G-CSF for SCI and acute aggravation of compressive myelopathy [13,14]. In the trial for compressive myelopathy, NeP was attenuated after G-CSF administration in 14/17 patients for several months.…”

Neuroprotective Effects of Direct Intrathecal Administration of Granulocyte Colony‐Stimulating Factor in Rats with Spinal Cord Injury

“…Our previous reports and several other recent studies have indicated that in addition to its hematopoietic effects, G‐CSF possesses nonhematopoietic functions and can be used as a potential drug for neurodegenerative diseases, including stroke and spinal cord ischemic, mechanical, and transection injuries . A phase I/IIa clinical trial of SCI has reported neurological improvement after G‐CSF administration . Based on primary safety endpoints of clinical trial IIa, Schabitz et al.…”

A Systematic Review of Experimental Strategies Aimed at Improving Motor Function after Acute and Chronic Spinal Cord Injury

“…No significant differences were found, however, when comparisons were made to a database control group. 33 In a subsequent study in 37 participants with incomplete cervical SCI, Inada and coworkers 34 found that the same dose of G-CSF as used by Takahashi and colleagues 33 was associated with greater improvements in AIS motor scores than a control group at 1 year post-transplantation. Unfortunately, participants were allocated to the experimental group based on the institution they were treated at (in a nonrandomized manner), and it was not possible to assess whether clinical management differed between the sites.…”

“…Greatest improvements were made by those classified AIS B at study entry. 32 Takahashi and colleagues 33 performed a Phase II study to assess the effects of granulocyte colony-stimulating factor (G-CSF), a compound shown to suppress neuronal apoptosis and expression of inflammatory cytokines. Sixteen participants injured less than 48 h before study enrollment received an intravenous dose of 10 lg/kg/ day for 5 consecutive days and demonstrated significant improvements in the ASIA Impairment Scale (AIS) motor scores on the follow-up assessment performed 3 months later when compared with the pre-intervention assessment.…”