10.29.14
The U.S. Food and Drug Administration has expanded the protocol for InVivo Therapeutics Holdings Corp.’s ongoing IDE (investigational device exemption) pilot trial for acut spinal cord injury (SCI), including expanding the number of allowable clinical sites to 20 (previously 6) and broadening the eligibility criteria. With this approval, the upper end of the age range has been increased from 55 to 65, the spinal cord injury level has been expanded from T3-T11 to T3-T12/L1, the enrollment window has been extended from 10 to 21 days post injury, and the body mass index upper limit has been increased from 35 to 39.
“We have been working closely with the FDA to optimize enrollment for our acute SCI trial and are very pleased with this approval,” said CEO Mark Perrin. “We continue to take a proactive approach in broadening such critical variables to expedite subject enrollment.”
The Cambridge, Mass.-based company’s biodegradable neuro-spinal scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure in preclinical models of spinal cord contusion injury. In addition to IDE status, the scaffold has received a humanitarian use device designation.
“We have been working closely with the FDA to optimize enrollment for our acute SCI trial and are very pleased with this approval,” said CEO Mark Perrin. “We continue to take a proactive approach in broadening such critical variables to expedite subject enrollment.”
The Cambridge, Mass.-based company’s biodegradable neuro-spinal scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure in preclinical models of spinal cord contusion injury. In addition to IDE status, the scaffold has received a humanitarian use device designation.