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Paralysis Patients Report Gains in Sensory Function After Stem Cells Treatment

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The patients were part of a Phase I/II clinical trial of StemCells Inc.'s proprietary HuCNS-SC® product candidate (purified human neural stem cells) for chronic spinal cord injury. In addition to assessing safety, the trial is assessing changes in sensation, motor function, bowel/bladder function and other clinical endpoints. It is being conducted at Balgrist University Hospital, University of Zurich. StemCells is a biotech company based in Newark, California (US).

Results of the trial to date were presented last week by lead investigator Armin Curt, M.D., at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London. Dr. Curt is professor and chairman of Balgrist University Hospital's Spinal Cord Injury Center.

"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," he said. "Sensory function of all these patients was stable before transplantation, so the reappearance of sensation is rather unexpected.

"We are very intrigued to see that two of the three patients have gained considerable sensory function."

Patients in the study's first cohort all suffered a complete injury to the thoracic, or chest-level, spinal cord, which means they had no neurological function below the level of their injury. All three patients were transplanted four to nine months after injury with a dose of 20 million cells at the site of injury. The surgery, immuno-suppression and the cell transplants have been well tolerated by all the patients.

Changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent areas below the level of injury in two of the patients, while no changes were observed in the third.

In all a dozen patients with thoracic neurological injuries at the T2-T11 level are planned for enrollment. Their injuries must have occurred within three to 12 months prior to transplantation of the cells. The second and third cohorts will consist of patients who have less severe injury than the first group.

Enrollment for the second cohort is now underway.

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StemCells, Inc.