Last week Business Wire reported that the Cambridge, Massachusetts-based medical device developer, InVivo Therapeutics Corporation, expects to begin a human study into their new technology to treat spinal cord injuries soon. This technology uses “biopolymer scaffolding to treat acute spinal cord injuries,” the news source reports.
This technology represents a potentially unprecedented ability to treat spinal cord injury patients. At the moment, no spinal cord injury treatment options exist.
To treat these spinal cord injuries, doctors insert this polymer medical device into the area of the injury. Results of the testing of this method were published in a 2010 issue of the Journal of Neuroscience Methods. That study used four African green monkeys to test the treatment.
According to a recent WFMY News article, monkeys who received this treatment have shown the most progress, with one being able to walk again after only a few days. These results have been replicated in other animal testing research, including studies using rats.
During their meeting with the U.S. Food and Drug Administration (FDA), InVivo discussed “the Investigational Device Exemption (“IDE”) application previously filed by InVivo for its biopolymer scaffolding to treat acute spinal cord injuries.” The FDA must approve the IDE filing before clinical studies can begin with humans. However, Business Wire reports that “the FDA has agreed to an open dialogue as part of the final process toward gaining approval.”
Frank Reynolds, InVivo’s Chief Executive Officer, explains that after their meeting, he is “encouraged by the communication we have had with the FDA to this point, and pending approval of the IDE, we expect the clinical trial for our treatment of acute spinal cord injuries to commence during the second half of 2012.” The business report explains that InVivo also plans to “submit hydrogel-based applications to the FDA for the treatments of SCI and chronic pain” later this year.
InVivo Therapeutics was founded in 2005 by Reynolds, who sustained a paralyzing spine injury in 1992. According to the company, it prides itself on what it calls an “unmatched development portfolio composed of platform technologies for the treatment of both spinal cord injury and other application.”