The FDA approved a protocol amendment for InVivo's ongoing pilot INSPIRE study, making it a pivotal probable benefit study.
The study is titled "INSPIRE Study: 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." Here are five key notes:
1. The study is currently approved to enroll up to 12 patients. However, the company expects the FDA to approve a full 20 patients following completed six-month data review for the first five patients.
2. InVivo plans to submit the six-month data for the first five patients in the second quarter of this year.
3. The study tests the biodegradable Neuro-Spinal Scaffold surgically implanted at the epicenter of the wound designed to act as a physical substrate for nerve sprouting. A preclinical model for spinal cord contusion injury shows spare spinal cord tissue appositional healing, decreased post-traumatic cyst formation and decreased spinal cord tissue pressure.
4. The trial received a Humanitarian Use Device designation and is currently being studied as an Investigational Device Exemption study to treat patients with complete AIS A traumatic acute spinal cord injury.
5. The fifth patient was enrolled in September and previous patients have shown improvement.