Becker's Spine Review

33 PRACTICE MANAGEMENT SPINE DEVICE & INNOVATION The Endless Possibilities in Spine Biologics, Artificial Disc & Outpatient Procedures By Laura Dyrda D omagoj Coric, MD, chief of neu- rosurgery at Carolinas Medical Center and surgeon at Carolina Neurosurgery & Spine Associates, has his pulse on the developmental technologies in spine biologics and motion-preservation technology. He is currently participating in three clinical trials examining less invasive biologic disc repair as well as artifi- cial disc replacements that improve on traditional open procedures in both clinical quality and cost. "e way spine surgery developed was backwards; they developed the most invasive procedure first, that's the fusion procedure, and the less invasive treatments are still coming down the pipe," he says. "e fusion procedures are a big operation done under general anesthesia and the patient has to stay in the hospital for multiple days. Now we're working toward less invasive procedures that preserve the anatomy and allow pa- tients to go home the same day." ere is great potential for both innovations, depending on how far along the patient is with degenerative disc disease. Biologic disc repair Currently, surgeons have nonsurgical treatment options for patients in the beginning stages of DDD and fusion for patients at the end stages, but not much in between. at could change over the next few years, depending on the outcome of clinical studies examining disc repair. "With biologic disc repair, you will see the potential for less intensive treatment, lower cost and less recov- ery time for a more patient-friendly, outpatient procedure," says Dr. Coric. "It's really akin to an epidural ste- roid injection, but here you have the potential for repair as opposed to just the anti-inflammatory effect." Dr. Coric and his team are in- volved in two studies with disc regen- eration injections: the Mesoblast and ISTO Technologies' NuQu clinical trials. ey are preparing for Phase III of the Mesoblast study that will com- pare Mesoblast stem cell injection to saline injections. e previous Phase II clinical trial showed the Mesoblast injection is most effective with 6 million cells per cc of injection as opposed to 18 million cells, so they'll use 6 million cells per cc in Phase III. e NuQu injectable juvenile cartilage disc repair has completed Phase II, and researchers are waiting until they hit the two-year follow-up mark with their current patients before moving on to Phase III, which could start later this year. "ese investigational treatments offer the potential to treat patients with DDD in a minimally invasive outpatient fashion," says Dr. Coric. "Using these biologics, we're able to perform the injection under local anesthesia. It takes about five to 10 minutes to complete the procedure, and the injection is only about 30 to 45 seconds long. It doesn't involve a major procedure and potentially offers the hope to repair the disc as opposed to obliterate it with fusion or disc replacement." e FDA hasn't yet approved any biologic disc repair treatments, but both the Mesoblast and NuQu trials are on their way. A third company, DiscGenics, is also working on a biologic treatment for disc repair and could go to the human trials next year. e DiscGenics procedure includes active disc cells that are cul- tured and injected into the disc space. "ere are several regenerative procedures moving through the process and it's exciting because it's a minimally invasive way to repair the disc," says Dr. Coric. "But at the end of the day, this is another tool that surgeons can incorporate into their practices. Like anything else, it's about patient selection. We can work with patients early on with isolated one-level disc disease and treat them before they become chronic nar- cotics users. It's a niche that needs to be filled, but it's not a cure-all for back pain so surgeons still need to be selective." Artificial disc replacement Biologic injections are one avenue to meeting cost and quality goals; picture here

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