Abstract
Few treatments have proven effective for patients with chronic spinal cord injury (SCI). This study aimed to evaluate the efficacy and safety of acidic fibroblast growth factor (aFGF) in human SCI. This was an open-label prospective clinical trial of aFGF with an extended follow-up to 48 months. All patients were treated with aFGF 3 times, including once directly applied to the injured spinal cord during neurolysis surgery, and twice via lumbar punctures at 3- and 6-months post-operation. Every patient was evaluated with standardized measurements of neurological functions. The trial initially enrolled 60 patients (30 cervical and 30 thoracolumbar SCI), but only 46 (21 cervical- and 25 thoracolumbar-SCI) completed the follow-up. The ASIA impairment scales, motor, pin prick, light touch, and FIM motor subtotal scores were all improved in both groups, except that the ASIA scores of light touch only demonstrated tendency of increase in the cervical-SCI group. All patients had a decrease in dependence, and there were no major adverse events or other oncological problems throughout the follow-up. At 48 months, the study demonstrated that aFGF was safe, feasible, and could yield modest functional improvement in chronic SCI patients. Further randomized control investigations are warranted for validation of its optimal dosage.
Highlights
Spinal cord injury (SCI) could be a devastating event and might tremendously affect the patients and their family, both physically and psychologically
The strategy of peripheral nerve grafting together with acidic fibroblast growth factor in fibrin glue was further proven to benefit the rodents with spinal cord injuries and cervical root injuries[5,6,7,8,9,10,11,12]
The clinical trial enrolled a total number of 60 participants (45 male and 15 female), divided into cervical (30 patients) and thoracolumbar (30 patients) groups based on the injury level
Summary
Spinal cord injury (SCI) could be a devastating event and might tremendously affect the patients and their family, both physically and psychologically. The clinical application of aFGF, with or without nerve grafting, was reported to advantage neurological function improvement after spinal cord injuries, cervical root injuries, brachial plexus injuries, and common peroneal nerve injuries in human patients[16,17,18,19,20,21,22]. Based on these inspiring results, a prospective clinical trial about the application of aFGF to injured spinal cords was conducted[23]. As an extension of the trial, the current study aims to evaluate the long-term efficacy and safety of aFGF usage in combination with surgical intervention for human spinal cord injury
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