StemCells Reports Positive Results On Thoracic Spinal Cord Injury Study

(RTTNews) - StemCells Inc. (STEM) announced the positive top-line results of its thoracic spinal cord injury phase i/ii study.

The company said that Armin Curt, principal investigator, will present a summary of the safety and preliminary efficacy data from the Phase I/II study investigating Human Central Nervous System Stem Cell (HuCNS-SC) intramedullary transplantation in thoracic spinal cord injury.

The international, open-label, Phase I/II trial evaluated both safety and preliminary efficacy of StemCells, Inc.'s proprietary HuCNS-SC human neural stem cells as a treatment for chronic spinal cord injury. The trial enrolled twelve patients who had suffered injury to the thoracic cord and were in the early chronic stage of recovery.

The severity of spinal cord trauma is classified by the ASIA Impairment Scale (AIS) according to the degree of sensory and motor loss. Patients classified as AIS A, the most severe injury, have lost both sensory and motor function below the level of injury. AIS B patients are considered less severely injured because, although they also have no motor function below the level of injury, some limited sensory function is maintained. The protocol was specifically designed to test safety and preliminary efficacy across this spectrum of injury severity, and ultimately the trial transplanted seven AIS A and five AIS B patients.

The analysis of the study demonstrated that the surgical transplantation technique and cell dose were safe and well tolerated by all patients. HuCNS-SC cells were injected directly into the cord both above and below the level of injury and sequential examinations of the patients over the course of twelve months showed no abnormal changes in spinal cord function associated with the transplantation technique. There were no adverse events attributed to the HuCNS-SC cells.

In addition to safety, analysis of the twelve-month data revealed sustained improvements in sensory function that emerged consistently around three months after transplantation and persisted until the end of the study. The patterns of sensory gains were confirmed to involve multiple sensory pathways and were observed more frequently in the patients with less severe injury; three of the seven AIS A patients and four of the five AIS B patients showed signs of positive sensory gains confirming the previously released interim results. In addition, two patients progressed during the study from the most severe classification, AIS A, to the lesser degree of injury grade, AIS B.