Just got an email this morning.
Neuralstem Expands Phase 1 Safety Trial of NSI-566 Neural Stem Cells in Spinal Injury
Investigating New Patient Cohort with Cervical Injury
GERMANTOWN, Md., April 12, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, announced that a new cohort of four patients will be added to its ongoing Phase 1 human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair chronic spinal cord injury (cSCI). The amended protocol was approved by the U.S. Food and Drug Administration and the Institutional Review Board at the study site, University of California San Diego (UCSD). NSI-566 is Neuralstem?s lead stem cell therapy candidate.
Under the amended protocol, updated on clinicaltrials.gov (NCT01772810), four qualifying patients with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 cord will be added to the study. The injury must have occurred 1-2 years prior to the time of stem cell treatment, which is a one-time surgery involving six injections of NSI-566 into the affected area of the cord. The study has begun active recruitment of patients.
About 250,000 Americans are living with cSCI, and approximately 11,000 new injuries are reported each year1. Roughly 52% of these individuals will be considered paraplegic and 47% will be considered quadriplegic1. cSCI is a permanent and disabling condition with few to no treatments. Its devastating effect can be measured from social, healthcare, and economic perspectives.
"This expansion of the study to cervical injuries builds on the results demonstrating that the implantation of NSI-566 stem cells in the first four patients with AIS-A complete thoracic cSCI was safe and feasible with no serious adverse events," said Karl Johe, Ph.D., Chief Scientific Officer, Neuralstem. "There is a tremendous unmet need in the treatment of cSCI and we are privileged to have the experts at UCSD School of Medicine and the Sanford Stem Cell Clinical Center at UC San Diego Health conducting the research. We look forward to further evaluating NSI-566 neural stem cells in chronic complete cervical injuries."
Long-term safety data from the first cohort of chronic complete thoracic injuries is currently being analyzed by the study team at UCSD School of Medicine.
Kinda sucks that they are only looking for patients that are 1-2 years post injury! Nevertheless I'm glad they expanded the trail!