Neuralstem, Inc., a biopharmaceutical company, announced that it completed the first surgery in the second, cervical injury cohort of a phase 1 clinical trial in patients with chronic spinal cord injury (cSCI).  NSI-566 is Neuralstem’s lead stem cell therapy candidate.

“This study involves complete injury patients with no motor or sensory function below injury. The first four paraplegic cases with thoracic injury went exceptionally well. We are excited to move forward with the next four quadriplegic cases with cervical injury,” said Karl Johe, Ph.D., the chief scientific officer of Neuralstem.

Neuralstem is conducting a phase 1 human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI. The clinical trial is being conducted at the University of California San Diego, Division of Neurosurgery. In April 2017, the clinical trial was expanded to include a new cohort of four qualifying patients with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 of their spinal cord, after promising results were observed with the first cohort. The clinical trial is evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI. The amended protocol was approved by the US Food and Drug Administration and the Institutional Review Board at the study site, University of California San Diego (UCSD) and can be found on clinicaltrials.gov (NCT01772810). The first surgery for the second cohort was completed on March 28.

According to the National Spinal Cord Injury Statistical Center at UAB, as of 2015, about 250,000 Americans are living with cSCI, and approximately 11,000 new injuries are reported each year. Approximately, 52% of these individuals will be considered paraplegic and 47% will be considered quadriplegic. cSCI is a permanent and disabling condition with few to no treatments. Its devastating effect can be measured from social, healthcare, and economic perspectives.

Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need.