Polylaminin-Mediated Axonal Regeneration in Complete Spinal Cord Injury: Documentation of Experimental Results and ANVISA Phase 1 Clinical Trial Authorization

Background: Complete spinal cord injury (SCI) results in permanent loss of motor and sensory function below the lesion level due to disrupted neuronal connectivity. Currently, no effective treatment exists for regenerating damaged neural pathways in humans. Methods: Between 2018 and 2024, researchers at the Federal University of Rio de Janeiro (UFRJ) conducted experimental treatments involving eight patients with complete spinal cord lesions. Each patient received a single intralesional injection of polylaminin—a reconstituted extracellular matrix protein extracted from human placentas—within 72 hours post-injury. The experimental procedures were performed under ethics committee approval. On January 5, 2026, the Brazilian National Health Surveillance Agency (ANVISA) authorized the initiation of formal Phase 1 clinical trials. Results: Of the eight patients who received experimental polylaminin treatment, two died from accident-related complications unrelated to the intervention. Among the six surviving patients, all demonstrated varying degrees of motor function recovery. Functional improvements included lower limb movement, upper limb function restoration, trunk control, and, in remarkable cases, independent ambulation. These findings represent the first documented evidence of substantial motor recovery following complete SCI in humans through a regenerative therapeutic approach. Conclusions: Experimental administration of polylaminin within 72 hours of complete spinal cord injury appears to promote axonal regeneration and restore neural connectivity, leading to clinically significant motor function recovery. ANVISA’s January 2026 authorization of Phase 1 clinical trials marks a critical regulatory milestone. This discovery represents a paradigm shift in SCI treatment and warrants rigorous clinical validation. Researcher responsible for the study at the link: http://lattes.cnpq.br/2832146111472321