The first trial to use neural stem cell transplants as a treatment for spinal cord damage has found a regain in sensation in some patients who had no neurological function below their thoracic injury.
The trial, a Phase I/II study of StemCells' proprietary HuCNS-SC product, involved transplanting three patients with a dose of 20 million cells at the thoracic site of injury to determine the safety and preliminary efficacy of the purified human neural stem cell treatment.
The results, which StemCells announced as part of their six-months interim data, showed two of the patients had changes in sensitivity to touch, heat and electrical stimuli in well-defined and consistent areas below the level of injury, while no changes were observed in the third patient.
All three patients suffered a complete injury to the thoracic spinal cord, meaning they had no neurological function below it.
University of Zurich Balgrist University Hospital Spinal Cord Injury Centre professor and chairman Dr Curt said the transplantations have been tolerated well by all three patients, and there are no safety concerns.
"We are very intrigued to see that two of the three patients have gained considerable sensory function," Curt said.
"The gains in sensation have evolved in a progressive pattern below the level of injury and are unanticipated in spinal cord injury patients with this severity of injury, suggesting that the neural stem cells are having a beneficial clinical effect.
"Sensory function of all these patients was stable before transplantation, so the reappearance of sensation is rather unexpected."
StemCells CNS programme vice president and head Dr Stephen Huhn said the company is collecting more data to establish efficacy.
"We are pushing ahead with our trial and plan to dose the first patient with an incomplete injury soon," Huhn said.
Enrolment for the second cohort is underway, according to the company.