InVivo Therapeutics (NSDQ:NVIV) said today it added a new site to the ongoing Inspire clinical study of its neuro-spinal scaffold designed to treat patients with complete thoracic AIS A spinal cord injuries..
The new site is located at the Allegheny General Hospital in Pittsburgh, Penn., and brings the total number of centers in the trial up to 26.
The company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
“My research interests lie at the intersection of neuro-oncology and spinal disorders. While we routinely enter the spinal cord to remove tumors, the Inspire study is the first opportunity that affords us the ability to enter the spinal cord in trauma cases. I look forward to being a part of this study, which has the potential to change the standard of care,” study site principal investigator Dr. Terrence Julien said in prepared remarks.
“We are pleased to welcome Dr. Julien and his team at Allegheny General Hospital to the Inspire study. We continue to add quality sites like AGH and look forward to adding more in the near future,” CEO Mark Perrin said in a press release.
The company added 2 new sites, at Boston’s Beth Israel Deaconess Medical Center and at Alberta, Canada’s Foothills Medical Center, to the study last month.
The Cambridge, Mass.-based company said in August that the Inspire trial’s conversion rate for improvement in the American Spinal Injury Assn.’s 50-point lower extremity motor score is 62.5% – more than double the trial’s objective performance criterion of 25% at 6 months.
InVivo said that the trial’s 9th spinal cord injury patient, implanted with its neuro-spinal scaffold last month, is already showing signs of improvement. The device is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
The trial’s 9th patient improved from a complete to incomplete spinal cord injury on the AIS scale between the 2nd and 3rd month after implantation; the patient is the 5th of 8 patients in the company’s Inspire study to show an AIS grade improvement, InVivo said.
In June, the company touted a case study of the 1st patient, showing improvement at 3 months to a Grade C incomplete injury and no procedural complications or safety issues at 6 months. That patient demonstrated an 8-point gain in AIS score and additional bilateral motor function improvements between the 6-month and 12-month follow-ups.
In July, InVivo said the FDA cleared an expansion of the Inspire study to up to 20 patients and announced the 9th and 10th implantations in the trial.