First-in-human clinical study found improved motor and sensory function in three of four participants
Writing in the June 1 issue of Cell Stem Cell, researchers at University of California San Diego School of Medicine report that a first-in-human phase I clinical trial in which neural stem cells were transplanted into participants with chronic spinal cord injuries produced measurable improvement in three of four subjects, with no serious adverse effects.
- Four biotech companies are pursuing the treatment of spinal cord injury with the use of stem cell transplantation.
- Each company demonstrated efficacy in pre-clinical studies.
- The race is in the early stages but InVivo Therapeutics is clearly leading the pack based on its strategic approach to accelerated HDE approval and initial trial results.
Neuralstem, announced that the Institutional Review Board of the University of California, San Diego, School of Medicine has approved the phase I safety trial to treat chronic spinal cord injury (cSCI) with its NSI-566 stem cells. The NSI-566/cSCI phase I trial will enroll patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury. AIS A impairment, which is complete paralysis, refers to a patient with no motor or sensory function in the relevant segments at and below the injury.