An early-stage trial of StemCells’ purified human neural stem cells in patients with complete spinal cord injuries restored enough sensation in a patient to reclassify him to an incomplete spinal cord injury, a first according to the company.

The patient was one of a cohort of three patients with spinal cord injuries that left them with no feeling below the site of the injury. The newly reported results come after one year of administering the stem cells and showed that two patients in the study that had improved sensory function at six months continued to improve. The third patient remained stable.

Though the company cautions the results are early, findings from the first cohort of patients are considered promising as StemCells moves toward dosing cohorts with less severe injuries. The study will look at a total of 12 patients with chest-level spinal cord industry that occurred within three to twelve months prior to transplantation of the cells. In addition to assessing safety, the trial seeks to assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor function, bowel, and bladder function.

“While we need to be cautious when interpreting data from a small, uncontrolled trial, to our knowledge, this is the first time a patient with a complete spinal cord injury has been converted to a patient with an incomplete injury following transplantation of neural stem cells,” says Martin McGlynn, president and CEO of StemCells. “We are encouraged that the cells appear to convey clinical benefit in such severely injured patients.”

McGlynn says the company is hopeful that it will see similar or greater benefit in new patients that already have partial sensation and motor function below the level of injury which could be further augmented by cell transplantation.

All three patients in the initial cohort were transplanted four to nine months after injury with a dose of 20 million cells at the site of injury. The surgery, immunosuppression, and the cell transplants have been well tolerated by all the patients, the company says. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients have remained neurologically stable through the first 12 months following transplantation.

Positive changes in sensitivity to touch, heat and electrical stimuli were observed in two of the patients, while no changes were observed in the third patient. Quantitative tests of specific sensory function, as well as electrophysiological measures of impulse transmission across the site of injury, provided further confirmation of the sensory gains.

“Importantly, the persistence of these sensory gains at the 12-month evaluation was seen across more than one clinical measure,” says Armin Curt, Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich and principal investigator of the clinical trial. “While much more clinical research needs to be done to demonstrate efficacy, the types of changes we are observing are unexpected and very encouraging given that these are patients in the chronic stage of complete spinal injury.”

Trading in StemCells closed February 12 at $1.99, a 20 percent increase from the previous day’s close.