InVivo Therapeutics Holdings Corp announced that the US Food and Drug Administration (US FDA) has approved various changes to the protocol for the company’s ongoing IDE pilot trial for acute spinal cord injury (SCI), including expanding the number of allowable clinical sites to 20 (previously six) 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.

Mark Perrin, InVivo’s CEO, said, “We have been working closely with the FDA to optimise enrollment for our acute SCI trial and are very pleased with this approval. We continue to take a proactive approach in broadening such critical variables to expedite subject enrollment.”