The INSPIRE Study
Research type
Research Study
Full title
The 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
IRAS ID
195032
Contact name
Manjunath Prasad
Contact email
Sponsor organisation
InVivo Therapeutics
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 28 days
Research summary
The purpose of this study is to assess the benefits and safety of a new medical device, the Neuro-Spinal Scaffold ™. The Scaffold is intended for use in patients age 16 – 70 years diagnosed with a T2 – T12/L1 (neurological spinal cord level) functionally complete spinal cord injury (AIS A) for whom open spine surgery (e.g., laminectomy, spine stabilization) which allows access to the dura of the injured spinal cord is recommended as an option. The Scaffold is intended to be implanted in a post-irrigation cavity at the epicenter of the spinal cord contusion during open spine surgery. The Scaffold is intended to act as a physical substrate for cell growth, appositional healing, and tissue remodeling, and preserve the structural integrity of the cord. The Scaffold is intended for use in recent (≤96 hours) spinal cord injuries that do not involve penetrating injury to the cord or complete severing of the cord.
You will be in the study for 10 years following your surgery and your doctor or nurse will ask you to complete an number of questionnaires , take blood tests and have scans. After year 2 you will receive a telephone call once a year to check on your progress
The study is funded by InVivo Therapeutics and is being carried out in two NHS hospitals in the UK
If you join the study, you will also receive all standard of care treatments by the doctors taking care of you for your type of injury.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0038
Date of REC Opinion
25 May 2017
REC opinion
Further Information Favourable Opinion