Anvisa Clears First Human Trial of UFRJ’s Polilaminina for Spinal Cord Injury

Overview

• Regulators approved a phase 1, single‑dose intramedullary study assessing safety in adults 18–72 with complete thoracic lesions between T2 and T10 occurring within 72 hours and requiring surgery.
• Trial sites will be designated by the sponsor, and any move to phases 2 and 3 will depend on initial safety findings.
• The authorization was granted through Anvisa’s Innovation Committee, which prioritizes evaluation of selected novel health technologies.
• The program formalizes testing after court-ordered applications outside research protocols hindered systematic follow‑up and data collection, according to researchers.
• Polilaminina reorganizes the laminin protein to support axon regrowth; prior animal work and eight early human applications showed varied functional improvements that require confirmation in controlled trials.