Intramedullary injection of polymerized laminin in acute traumatic spinal cord injury: a first-in-human pilot study

Study design Investigator-initiated, single-arm, first-in-human pilot study. Objectives To evaluate the safety and feasibility of intramedullary administration of polymerized laminin in individuals with acute complete spinal cord injury (SCI). Setting Public and private hospitals in Brazil. Methods Eight patients with acute traumatic SCI classified as AIS A (C4–T12) were enrolled within days after injury (mean 2.3 days). Polymerized laminin was administered as a single intramedullary dose (1 µg/kg; total 55–80 µg). Patients were followed for 12 months using standardized neurological, laboratory, and neurophysiological assessments. Results Intramedullary administration was uneventful in all cases. No neurological deterioration or serious adverse events attributable to the intervention were observed. Mild laboratory abnormalities were transient and not associated with hepatic or renal toxicity. Three participants died during follow-up. Deaths were reviewed by the Brazilian National Research Ethics Commission (CONEP) and an external clinical consultant, and were not considered related to the intervention. Neurological improvement of at least two AIS grades was observed in six participants, including one who died after progressing to AIS C. Improvements in motor and/or somatosensory evoked potentials were observed in three patients. Conclusions Intramedullary administration of polymerized laminin was uneventful and appeared to be safe in this small and heterogeneous cohort. Although the study design does not allow conclusions regarding efficacy, it provides proof-of-concept for this therapeutic approach and justifies further evaluation in controlled clinical studies. The study was initiated in December 2016, prior to current requirements for prospective trial registration.