FDA Conditionally Clears InVivo’s Probable Benefit Study
InVivo Therapeutics has received conditional approval from the FDA of a study protocol amendment that will convert its ongoing pilot of its Neuro-Spinal scaffold in acute spinal cord injury into a pivotal probable benefit study.
The approval is conditional upon what the company calls a minor change to the informed consent form already submitted to the FDA, although full approval is expected in the next 30 days.
The INSPIRE study — which has a primary endpoint of the proportion of patients achieving an improvement of at least one ASIA Impairment Scale grade at six months following the implantation — will enroll up to 20 patients.
The approval follows a six-month review by the FDA of the safety data from the five patients currently enrolled. — Michael Cipriano