Acidic FGF facilitates recovery in motor score in AIS A spinal cord injured patients

Abstract

Abstract Acidic fibroblast growth factor (aFGF) is a potent neurotrophic factor that may uphold neuronal survival in the injured spinal cord. It has been reported to promote functional recovery in open-label clinical studies. The first randomized, double-blind, placebo-controlled study was conducted to verify aFGF’s efficacy and safety in SCI patients. Patients with AIS Grade A or B SCI were randomized into two arms and given either aFGF or placebo every 4 weeks for total 3 doses. All patients were evaluated for medical, neurological, and functional changes at baseline, then every 4 weeks after the first dose of aFGF/placebo until 48 weeks. The first dose was administered directly to the injured site at the surgery within 6 weeks after SCI, and the 2nd and 3rd doses were given through lumbar puncture. Due to the impact of COVID-19 pandemic the study ended prematurely; nevertheless, explorative analyses revealed encouraging signals of the beneficial effect of aFGF albeit with a limited sample size. This is the first clinical report showing that aFGF may reduce myelomalacia and accelerate motor recovery in complete SCI patients with a significantly higher chance to achieve a 10-point improvement (Odds ratio = 6.06). Further studies to validate aFGF’s clinical efficacy are warranted.