StemCells, Inc. started its Phase I/II clinical trial of treating chronic spinal cord injury with adult neural stem cells in September, 2011, and administered cells to the first participant at Balgrist University Hospital, University of Zurich. This is the first in the world that adult neural stem cells are transplanted.
Earlier, StemCells, Inc. conducted preclinical studies that demonstrated healing potential of neural stem cells in treating spinal cord injury. Now, they’ve started clinical trials and transplanted the cells to a male 23-year-old participant from Germany. The young man got injured in April 2011 and lost the sensation and mobility below his waist, and the hope of cure made him participate in the trials.
The company plans to treat with neural stem cells the first cohort with the most severe spinal cord injury by the end of the year. Later, the patients with less severe injury will be treated. This trial design will enable the research team to assess the potential of neural stem cells in treating spinal cord patients with the different level of injury severity.
During the trial, the safety and effectiveness of neural stem cells in treating spinal cord injuries will be assessed. It is planned to enroll 12 patients with chest-level injuries with injuries ranging from the most to less severe. Apart from assessing treatment safety, treatment effects such as influence on motor function, sensation, etc. will be measured.
All trial participants will be injected neural stem cells in their spinal cords and temporarily given immunosuppression. After the treatment, they will be followed up to assess the safety of both cells and surgery and to measure neurological effects. After that, a 4-year observational study will be conducted.