InVivo Therapeutics (NSDQ:NVIV) said today it added the University of California, San Diego Medical Center as a site for its Inspire pivotal clinical trial examining its Neuro-Spinal Scaffold designed to treat acute spinal cord injuries.
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 new location brings the total number of sites for the pilot-turned-pivotal trial up to 15, Cambridge, Mass.-based InVivo said. Dr. Joseph Ciacci will operate as principal investigator of the new site.
“My team and facility are well-suited for a clinical trial in this area. I look forward to being a part of this study,” Ciacci said in a press release.
“Dr. Ciacci and the team at the UC San Diego Medical Center serve as a valuable addition to our clinical network for The INSPIRE Study,” CEO Mark Perrin said in prepared remarks.
Last month, InVivo Therapeutics said it won FDA approval to shift the Inspire pilot trial of its spinal scaffold to a pivotal probable benefit study.
InVivo said it expects the FDA to OK its Inspire study, designed to enroll 20 patients with spinal cord injuries, after it submits 6-month data during the 2nd quarter from 5 patients already enrolled in the pilot study. The company said it’s discussing the Inspire study’s objective performance criterion for probable benefit, using historical benchmarks, with the federal safety watchdog.