biostudies-literatureMaynard GNCATS NIH HHSNIA NIH HHSNIDA NIH HHSNINDS NIH HHSNIH HHS672-684https://www.ebi.ac.uk/biostudies/studies/S-EPMC10410101biostudies-literatureUnknown22(8)<h4>Background</h4>Spinal cord injury (SCI) causes neural disconnection and persistent neurological deficits, so axon sprouting and plasticity might promote recovery. Soluble Nogo-Receptor-Fc decoy (AXER-204) blocks inhibitors of axon growth and promotes recovery of motor function after SCI in animals. This first-in-human and randomised trial sought to determine primarily the safety and pharmacokinetics of AXER-204 in individuals with chronic SCI, and secondarily its effect on recovery.<h4>Methods</h4>We conducted a two-part study in adults (aged 18-65 years) with chronic (>1 year) cervical traumatic SCI at six rehabilitation centres in the USA. In part 1, AXER-204 was delivered open label as single intrathecal doses of 3 mg, 30 mg, 90 mg, or 200 mg, with primary outcomes of safety and phaThe Lancet. NeurologySoluble Nogo-Receptor-Fc decoy (AXER-204) in patients with chronic cervical spinal cord injury in the USA: a first-in-human and randomised clinical trial.PMC10410101S10 OD018034R01 AG034924S10 OD019967UL1 TR001863P30 DA018343R01 NS118200R44 NS118974R35 NS097283Liu JSchwab JMMarino RBlock GFlanders AMaynard GLeslie DPZafonte RSmith EChen DKannan RHackett CWang WLam TKTWang XLiu CAdamson CStrittmatter SMfalseSoluble Nogo-Receptor-Fc decoy (AXER-204) in patients with chronic cervical spinal cord injury in the USA: a first-in-human and randomised clinical trial.<h4>Background</h4>Spinal cord injury (SCI) causes neural disconnection and persistent neurological deficits, so axon sprouting and plasticity might promote recovery. Soluble Nogo-Receptor-Fc decoy (AXER-204) blocks inhibitors of axon growth and promotes recovery of motor function after SCI in animals. This first-in-human and randomised trial sought to determine primarily the safety and pharmacokinetics of AXER-204 in individuals with chronic SCI, and secondarily its effect on recovery.<h4>Methods</h4>We conducted a two-part study in adults (aged 18-65 years) with chronic (>1 year) cervical traumatic SCI at six rehabilitation centres in the USA. In part 1, AXER-204 was delivered open label as single intrathecal doses of 3 mg, 30 mg, 90 mg, or 200 mg, with primary outcomes of safety and pha2023-01-01T00:00:00Z2023 Aug2026-06-02T22:07:26.047Z2025-05-29T19:05:32.756ZS-EPMC104101013747937310.1016/S1474-4422(23)00215-610.1016/s1474-4422(23)00215-6