About the Trial
The trial is designed to assess both safety and preliminary efficacy. The trial will enroll 12 patients with thoracic (chest-level) spinal cord injury who have a neurological injury level of T2-T11, and will include both complete and incomplete injuries as classified by the American Spinal Injury Association (ASIA) Impairment Scale. The first cohort will be patients classified as ASIA A, or patients who have what is considered to be a "complete" injury, or no movement or feeling below the level of the injury. The second cohort will progress to patients classified as ASIA B, or patients with some degree of feeling below the injury. The third cohort will consist of patients classified as ASIA C, or patients with some degree of movement below the injury. In addition to assessing safety, the trial will measure 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. Following transplantation, the patients will be evaluated regularly over a 12-month period in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells, the surgery and the immunosuppression, and to measure any recovery of neurological function below the injury site. As the Company intends to follow the effects of this therapy long-term, a separate four-year observational study will be initiated at the conclusion of this trial. For information on patient enrollment, interested parties may contact the study nurse either by phone at +41 44 386 39 01, or by email at email@example.com.
Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm , including video interviews with Company executives and independent collaborators.
About Chronic Spinal Cord InjuryChronic spinal cord injury is characterized as a continuum of time after injury, which starts when inflammation has stabilized and behavioral recovery is reaching a plateau. The chronic phase typically does not set in until several months following the injury. To date, treatment approaches for neural repair and regeneration have generally targeted the acute and sub-acute time points, which are considered to be hours or days following injury. Restoring some degree of function for patients at later time points beyond the acute recovery phase could have a transformative impact on the field as there are no effective treatment options for these patients today. StemCells hopes to address a broad population of spinal cord-injured patients by opening the window of opportunity for therapeutic intervention to months or longer post-injury, and by targeting a wide range of injury levels and degrees of impairment.
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