A patient enrolled into InVivo Therapeutics' INSPIRE Study, focused on spinal cord injury patients, has died due to causes unrelated to the investigational product.
Here are six things to know:
1. The patient died due to injuries from a severe motor vehicle accident.
2. The patient was the eighth enrolled in the study.
3. The Neuro-Spinal Scaffold, the subject of the study, was implanted in the patient around 72 hours after the accident.
4. The patient succumbed to the injuries two days later. The cause of death was determined unrelated to the Neuro-Spinal Scaffold device or implantation procedure by the principal investigator of the study.
5. The FDA and Data and Safety Monitoring Board will review the case.
6. Enrollment for the study remains open.