{"id":27709,"date":"2015-09-08T11:33:44","date_gmt":"2015-09-08T15:33:44","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=27709"},"modified":"2016-06-11T12:25:02","modified_gmt":"2016-06-11T16:25:02","slug":"spinal-cord-injury-device-trial-completes-enrollment","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=27709","title":{"rendered":"Spinal Cord Injury Device Trial Completes Enrollment"},"content":{"rendered":"
\"Spine<\/a>
(Michael Dorausch, Flickr)<\/figcaption><\/figure>\n

8 September 2015. An early-stage clinical trial testing an implanted biocompatible plastic framework to encourage healing of spinal cord injuries completed its initial enrollment. The Neuro-Spinal Scaffold device is made by InVivo Therapeutics Holdings Corp. in Cambridge, Massachusetts.<\/p>\n

Spinal cord injuries<\/a>\u00a0<\/span>are usually caused by a sudden, traumatic blow to the spine that bruises or tears into spinal cord tissue, resulting in fractures or compression to vertebrae, or in some cases severing of the spinal cord. Depending on severity, people with spinal cord injuries often suffer loss of feeling or motor function in the limbs, and in some cases complete paralysis. According to the\u00a0<\/span>National Spinal Cord Injury Statistical Center<\/a>, spinal cord injuries occur in 40 out of 1 million people in the U.S., adding some 12,500 new cases each year.<\/p>\n

The Neuro-Spinal Scaffold<\/a>, says the company, is designed for surgical implantation at the site of the injury, to provide structural support and a matrix on which new nerve cells can regrow. The scaffold’s framework is made of poly lactic-co-glycolic acid, or PLGA<\/a>, a polymer material used in sutures that breaks down and absorbed into the body. The device is coated with poly-lysine<\/a>, also a biocompatible polymer, used as a coating on culture dishes and slides that enhances electrostatic attraction of cell membranes, in this case to encourage regrowth of nerve cells.<\/span><\/p>\n

The clinical trial<\/a> is a pilot study to evaluate the safety and feasibility of the Neuro-Spinal Scaffold, as well as gather early clinical evidence of its efficacy. Researchers will look for adverse effects of any kind, and record changes in functional impairment using a standard measurement scale<\/a> at several times over the 12 months following implantation of the device.<\/p>\n

The study planned to enroll five patients and recruited its fifth patient at University of Southern California medical center in Los Angeles. Mark Perrin, InVivo’s CEO and chairman says in a company statement<\/a>, “we intend to request expanding the number of patients in the current pilot study beyond five to further compress clinical timelines. We anticipate that we will receive formal approval of this expansion within the next two months.”<\/p>\n

The technology<\/a> underlying the biopolymer scaffolds and related therapies in development at InVivo is based on research by Robert Langer of MIT and Joseph Vacanti of Massachusetts General Hospital, affiliated with Harvard University, that InVivo licensed from the institutions. Langer is a scientific advisor<\/a> to the company.<\/p>\n

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