Spinal cord · 2026
Intramedullary injection of polymerized laminin in acute traumatic spinal cord injury: a first-in-human pilot study.
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Lima Marco Aurelio B, Menezes Karla, Xerez Denise R, Côrtes Bruno A, Menezes João R L, Holanda Gustavo S, Silva Adriana D, Leite Eliel S, Franco Olavo B, Faria Marco Aurélio A M de, Forte Arthur de Freitas, Abreu Livia V, Lichtenberger Renata C L, Santana Cíntia F, Rosa Maurilio, Graça-Souza Aurélio V, Jorge Álvaro U C, Franzoi Ana Cristina, Ferreira Arthur S, Frajtag Rose M, Coelho-Sampaio Tatiana
Аннотация
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.
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.