POLYLAMININ FOR HUMAN SPINAL CORD INJURY

Background

Laminin is the extracellular cue endowing asymmetry to living beings. It is an extracellular matrix protein ubiquitously distributed in the animal body. In the nervous system, laminin modulates neuronal survival, differentiation, migration and axonal extension during embryonic development and regeneration. Polylaminin is an artificially stabilized form of laminin, previously shown to promote neuroprotection and axonal growth after spinal cord injury (SCI) in rodents. Here we report the results of a first in human trial of polylaminin to treat acute SCI.

Methods

This was an open-label, single-armed pilot study for patients diagnosed with functional complete SCI (AIS A) because only complete SCI have a well-established natural history, showing that spontaneous recovery of motor function is unlike to occur. The study was revised and approved by the Brazilian National Commission of Ethics in Medical Research (CAAE 3.474.884; U1111-1144-5390).  Safety was evaluated by clinical examination, laboratory tests, and monitorization of medical complications. Efficacy was assessed using the International Standards for Neurological Classification of Spinal Cord Injury.

Results

Eight participants were recruited in emergency hospitals in the states of Rio de Janeiro (7) and Minas Gerais (1) and received a single intraspinal injection of polylaminin (average time = 2.3 days). Two died within the first days of causes related to the gravity of the condition (broncho aspiration and pericardial effusion). The six patients that survived to reach the one-month follow-up regained voluntary motor control below the level of the lesion. None of the medical complications observed during the study was ascribed to the treatment.

Conclusions

Our results suggest that polylaminin is a safe and effective treatment for acute SCI, revealing its potential as a new therapy to restore motor function to paralyzed people.