StemCells shares rose in Thursday’s pre-market session after the stem-cell company released encouraging top-line results from a phase I/II study investigating human central-nervous-system stem-cell (or HuCNS-SC) intramedullary transplantation in thoracic spinal-cord injury. STEM was up 7.9% at $0.67 in recent pre-market trading, in a 52-week range of $0.54 to $2.43.
The trial evaluated both safety and preliminary efficacy of the company’s HuCNS-SC human neural stem cells as a treatment for chronic spinal-cord injury. The trial enrolled 12 patients who had suffered injury to the thoracic cord and were in the early chronic stage of recovery, with the protocol specifically designed to test safety and preliminary efficacy across the spectrum of injury severity.
“The analysis of the study demonstrated that the surgical transplantation technique and cell dose were safe and well tolerated by all patients,” the company said. It noted 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 12 months showed no abnormal changes in spinal cord function associated with the transplantation technique, while there were no adverse events attributed to the HuCNS-SC cells.
Analysis of the 12-month data also “revealed sustained improvements in sensory function that emerged consistently around three months after transplantation and persisted until the end of the study,” the company said.
“The gains we have detected indicate that areas of sensory function have returned in more than half the patients,” said Armin Curt, professor and chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich. “Such gains are unlikely to have occurred spontaneously given the average time from injury. This patient population represents a form of spinal cord injury that has historically defied responses to experimental therapies, and the measurable gains we have found strongly argue for a biological result of the transplanted cells.”