Here are four things to know.
1. The prospective INSPIRE (INvivo study of Probable Benefit of the Neuro-SPInal Scaffold for Safety and Neurologic REcovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) study which evaluated the device in 19 patients from 11 study sites.
2. All patients had complete SCI with T1 or T2 neurologic levels of injury, visible contusions on MRI but no cord transections or traumatic brain injuries and underwent open stabilization surgery less than 96 hours after the injury onset.
3. The trial’s primary endpoint was American Spinal Injury Association Impairment Scale conversion at 6 months. This was achieved in 44 percent of patients, greater than the 25 percent objective performance criterion of the study design.
4. The investigational scaffold device, a small porous biodegradable structure made of polyglycolic acid and polylysine, was implanted into the spinal cord at the injury site.
Written by Shayna Korol © Copyright ASC COMMUNICATIONS 2018.