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StemCells (STEM) First Neural Stem Cell Transplant in Spinal Cord Injury

STEM’s 1st patient in P1/2 clinical trial in chronic spinal cord injury was transplanted with the HuCNS-SC® adult neural stem cells.

 

The Bottom Line: The stem cells were administered 9/21/11 at Balgrist University Hospital, University of Zurich. With this 1st patient enrolled and dosed, STEM remains on track to meet its goal of treating the 1st cohort of patients by the end of this year. While the trial’s 1st cohort will consist of patients with the most severe, complete injury, the 2nd and 3rd cohorts will progress to patients with less severe, incomplete injury. The P1/2 clinical trial of HuCNS-SC purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. 12  patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The 1st 3 patients will all have injuries classified asASIA A, in which there is no apparent neurological function below the injury level.  The 2nd and 3rd cohorts will be patients classified as ASIA B and ASIA C, those with less severe injury, in which there is some preservation of sensory or motor function. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function. All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed.