InVivo Therapeutics (OTC:NVIV) said the FDA has given the company the green light to begin the first human clinical studies of its bioploymer scaffold, which treats traumatic spinal cord injury.
The Cambridge, Mass.-based company said it is gearing up for safety studies in 5 patients over 15 months, and is shooting for Institutional Review Board (IRB) approval at Massachusetts General Hospital.
The scaffold device is designed to prevent a 2nd injury in patients with traumatic spine injuries that don’t involve penetrated or severed spinal cords. There are currently no other treatment options for direct interventions in the spinal cord after an extreme spine injury, according to a company statement.
"It’s heartbreaking for all of us for it to take even a minute longer than necessary to begin human studies, and we’ve all heard of, or experienced, treatments that have proven to be unsafe, but when conducting a first-in-man study, it is imperative to take the time to get it right, because any mistakes can lead to years of lost time for the scientists and patients that follow," said Frank Reynolds, InVivo CEO in prepared remarks.
This scaffold has already been given humanitarian use device exemption, a designation the FDA doles out to treatments for "orphan" conditions.
