FDA OKs expansion of InVivo Therapeutics spinal scaffold study

InVivo Therapeutics (NSDQ:NVIV) said today that the FDA cleared an expansion of its Inspire study of its neuro-spinal scaffold, now set to enroll up to 20 patients, and announced the 9th and 10th implantation in the trial, though the 10th patient died of an unrelated stroke. The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. The federal watchdog cleared the company to expand the trial for up to 20 evaluable patients. The decision came based off the review of 6-month safety data from the trial, InVivo said. “We are pleased that the FDA has approved expansion of the Inspire study that clears the way for enrolling all 20 evaluable patients. While the pause in enrollment for the last several weeks was unfortunate, this approval is an important step toward our goal of approaching full enrollment of the Inspire study by the end of the year. As is typical of the regulatory process, we have addressed a number of study design considerations regarding the Inspire study and its pilot precursor study over the last 2 years. We have begun a constructive discussion with the FDA regarding this study design consideration, and we will provide an update if substantial changes are made to the study protocol. We continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a Humanitarian Device Exemption appl...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Spinal InVivo Therapeutics Corp. Source Type: news