- StemCells (STEM +5.2%) reports that the first patient has been transplanted with the company's proprietary HuCNS-SC (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI). The procedure was performed at the University of Miami as part of the Phase 2 Pathway Study, the first clinical trial designed to assess the safety and efficacy of transplanting human neural stem cells into patients with SCI. The trial will enroll up to 52 patients and follow participants for one year.
- The primary efficacy endpoint is the change in upper extremity strength (hands, arms, shoulders) measured according to the International Standards for Neurological Classification of Spinal Cord Injury.
- In May, the company completed enrollment and dosing in a Phase 1/2 trial in thoracic spinal cord injury. Post-transplant gains in sensory function below the level of injury were demonstrated in 6 of 12 patients. Two converted from a complete injury (AIS A) to an incomplete injury (AIS B).