Return Of Voluntary Motor Contraction After Complete Spinal Cord Injury: A Pilot Human Study On Polylaminin

Spinal cord injury (SCI) is still a major challenge for translational medicine. Polylaminin is a stabilized form of laminin, a natural multifunctional protein, previously shown to promote neuroprotection and axonal growth after SCI in rodents. Here we present the results of a confirmatory preclinical study performed in rats and of a first in human trial of polylaminin to treat acute SCI. The latter was an open-label, single-armed academic study designed to include only patients diagnosed with functional complete SCI, because no more than 15% of these patients recover motor function spontaneously. Eight participants received a single intraspinal injection of polylaminin shortly after trauma (average time = 2.3 days). Two died within the first days of causes related to the gravity of the condition. The six patients that survived to reach the one-month follow-up were evaluated using the International Standards for Neurological Classification of Spinal Cord Injury (6/6) and motor and somatosensory evoked potentials (3/6). All the six patients regained voluntary motor control below the level of the lesion, which is an unprecedented recovery. This preliminary study suggests the efficacy of polylaminin to treat acute SCI, revealing its potential as a new therapy to restore motor function to paralyzed people (UTN: U1111-1144-5390).