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FDA OKs Trial of Biopolymer to Treat Spinal Cord Injury

Model of spine (NIH)

(NIH)

InVivo Therapeutics, a medical device developer in Cambridge, Massachusetts, says it received approval from the U.S. Food and Drug Administration to begin a clinical trial to test the company’s bio-based polymer scaffolding as a treatment for acute traumatic spinal cord injury. The agency’s approval came in the form of an Investigational Device Exemption that allows medical devices with significant potential risk to be tested in clinical trials.

InVivo says its approach aims to protect the spinal cord after the initial injury by mitigating the bleeding, inflammation, and further cell death that result from the body’s immune response. This strategy, says the company, minimizes further injury and supports subsequent repair and recovery by sparing the surrounding healthy tissue. Other than regeneration, there are no other treatment options available, either FDA-approved or in clinical trials, adds the company.

Biopolymer scaffolding was examined in a preclinical study published in 2010 where researchers from university medical centers in Boston and Washington, D.C. created a model for spinal cord injury treatments using biodegradable polymer scaffolds seeded with human neural stem cells. The study involved implanting African green monkeys having injured spinal cords with polylactide-co-glycolide (PLGA) scaffolds, both with and without stem cells. The findings showed the subsequent injury healing and neurobehavioral observations could be measured and correlated, supporting the feasibility of human trials.

The clinical trial is expected to enroll five spinal cord injury patients to test the safety and initial efficacy of biopolymer scaffolds. The company plans to conduct the trial at multiple sites over 15 months, and has begun the process of review board approval at Massachusetts General Hospital in Boston. “Over the next month or so,” says InVivo CEO Frank Reynolds, “we plan to finalize the details of our study, and we expect to have all data to the FDA by the end of 2014.”

The technology underlying the biopolymer scaffolds and related therapies in development at InVivo is based on research by Robert Langer of MIT and Joseph Vacanti of Mass. General that InVivo licensed from the institutions. Langer was the senior author of the 2010 preclinical study and serves on InVivo’s scientific advisory board.

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