InVivo Therapeutics (NSDQ:NVIV) said today that Boston’s Beth Israel Deaconess Medical Center and Alberta, Canada’s Foothills Medical Center to the Inspire study of its neuro-spinal scaffold.
The additions bring the total number of sites up to 25 for the trial of the neuro-spinal scaffold, which is designed to treat patients with complete thoracic AIS A spinal cord injuries.
The neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
“We see many patients with spinal cord injuries, which makes us a great candidate for the Inspire study. There is a shortage of treatments for spinal cord injury and we look forward to being a part of this promising study,” principal investigator Dr. Martina Stippler of the Beth Israel Deaconess Medical Center said in prepared remarks.
“InVivo’s neuro-spinal scaffold is one of the more innovative approaches to treating acute spinal cord injury in recent history and we look forward to being a part of the Inspire study,” principal investigator Dr. Steven Casha of Foothills Medical Center said in a press release.
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.
