{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Maynard G"],"funding":["NCATS NIH HHS","NIA NIH HHS","NIDA NIH HHS","NINDS NIH HHS","NIH HHS"],"pagination":["672-684"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10410101"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["22(8)"],"pubmed_abstract":["<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 pha"],"journal":["The Lancet. Neurology"],"pubmed_title":["Soluble 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."],"pmcid":["PMC10410101"],"funding_grant_id":["S10 OD018034","R01 AG034924","S10 OD019967","UL1 TR001863","P30 DA018343","R01 NS118200","R44 NS118974","R35 NS097283"],"pubmed_authors":["Liu J","Schwab JM","Marino R","Block G","Flanders A","Maynard G","Leslie DP","Zafonte R","Smith E","Chen D","Kannan R","Hackett C","Wang W","Lam TKT","Wang X","Liu C","Adamson C","Strittmatter SM"],"additional_accession":[]},"is_claimable":false,"name":"Soluble 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.","description":"<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 pha","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Aug","modification":"2026-06-02T22:07:26.047Z","creation":"2025-05-29T19:05:32.756Z"},"accession":"S-EPMC10410101","cross_references":{"pubmed":["37479373"],"doi":["10.1016/S1474-4422(23)00215-6","10.1016/s1474-4422(23)00215-6"]}}