Technology which could transform the outlook for people living with spinal cord injury has seen its progress paused after a clinical study did not deliver its desired outcomes.
InVivo Therapeutics has created the Neuro Spinal Scaffold, a scaffold-based device being developed to support patients with acute SCI in neural regeneration and cell growth.
If implanted at the site of damage within one week of injury, InVivo Therapeutics claims the scaffold encourages functional cells to fill the cavity, and has the potential to improve sensory and motor function which could lead to a better quality of life for patients.
However, InVivo has announced that its INSPIRE 2.0 study did not meet its primary objective, which was assessed by the proportion of treated patients achieving an improvement of at least one American Spinal Injury Association (ASIA) Impairment Scale grade at six months post-scaffold implantation, versus a control group that received standard of care surgery.
The 20 patient study was based on promising INSPIRE 1.0 data.
“We are disappointed by the outcome of this study as treatments for spinal cord injury are so urgently needed and we know many in the SCI patient and advocate community wait in hope for therapeutic options,” says Dr Richard Toselli, president and CEO of InVivo.
“We have rigorously pursued the science and believe that, upon full assessment, the INSPIRE 2.0 data set will provide a significant addition to the clinical literature around the treatment of SCI.
“I extend our deepest thanks to our patients and clinical sites who have supported InVivo’s work to bring our science to patients, and the InVivo team who have tirelessly pursued our mission.”
In a statement, the company said that InVivo management will conduct a full assessment of the study data set and plans to share its findings in full in a peer-reviewed medical venue at a later date. It will also consider strategic options, it added.
