Six spine surgeons discuss key trends in spinal biologics.
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Question: What are key trends to expect in the biologics arena in the next five years?
Michael J. Musacchio, Jr., MD. Spine surgeon at NorthShore University HealthSystem's Neurological Institute (Chicago): Key trends in the biologics arena in the next five years will focus on efficacy and affordability. Much of this research and development is expensive, and so far, there has been little sound data to prove the effectiveness and superiority of one biologic over another in spine fusion. Our three general options — allograft, stem cells and synthetics — all show great potential, but more rigorous standards need to emerge before biologics replace the "gold standard," which uses the patients' own bone graft (autograft). If biological substitutes prove to be better at repairing and healing than a person's own bone, it may improve outcomes and reduce subsequent surgical interventions. This approach potentially will lower the risk of complications for patients and reduce overall healthcare costs.
Currently, bone allograft extender for spine fusion is getting the most attention. It is backed by sound research and is affordable. Demineralized bone matrix, which is the most common allograft used, has been proven effective in bone formation in the spine. The popular synthetic product known as bone morphogenetic protein might prevent a surgeon from removing bone as a graft from the patient's iliac crest, but it is unclear when it is most appropriate to use the substitute. The FDA-approved usages of BMP in spine surgery are narrow, and it is considerably more expensive than other options.
Stem cell research has been even more mysterious and expensive. Different testing standards have made ambiguous how best to prepare and deliver stem cells in spine surgery.
I anticipate more rigorous standards in research to better test the efficacy of biologics, and as more products go to market, I foresee competition driving down costs.
Luga Podesta, MD. Sports Medicine and Regenerative Orthopedic Specialist at Bluetail Medical Group (Naples, Fla.): A significant paradigm change will take place with regard to how orthopedic and musculoskeletal injuries and conditions are treated over the next half decade. We will see increasing laboratory and clinical research, further defining the biology of stem cells and bioactive proteins as well as defining safe and effective treatment pathways for common orthopedic conditions. The clinical use of these treatments will be shown effective as a first-line therapy or in conjunction with surgical therapies to augment the healing cascade.
With an expected increase in regenerative medicine treatments in clinical practice, I would expect to see tighter and more specific regulations by the FDA regarding the use of biologic and regenerative cell-based therapies over the next five years, with the purpose of eliminating false claims as to efficacy and scope of these treatments. We have already begun to see the FDA expanding guidelines as well as enforcing these guidelines for the purpose of ensuring the safety and efficacy of regenerative therapies.
Payam Farjoodi, MD. Orthopedic Spine Surgeon at Spine Health Center at MemorialCare Orange Coast Medical Center (Fountain Valley, Calif.): I would expect biologics to improve efficacy of fusion rates, while decreasing associated risks. With the backlash in the use of BMP routinely, there is a market need for an effective alternative that has a well-tested safety profile.
Brian R. Gantwerker, MD. Founder of the Craniospinal Center of Los Angeles: Biologics are still an expanding category in terms of what are the best and most reliable substances for achieving fusion. We will see more efficacious substances and, more importantly, we will see alternatives to bone morphogenic protein. Now that BMP is making a resurgence and being tested in fusion situations such as in TLIF or PLIF, we will see other substances boasting the same characteristics and efficacy, with increased safety.
BMP has a role in modern spine surgery, especially when utilized in osteoporotic, rheumatoid or pseudoarthrosis circumstances and should not be condemned or banned wholesale due to overly enthusiastic initial use.
J. Brian Gill, MD. Spine Surgeon at Nebraska Spine Hospital (Omaha): I think that you will continue to see better data to support the use of biologics, and I hope, data which shows superiority of one biologic over another.
Vladimir Sinkov, MD. Spine Surgeon at New Hampshire Orthopaedic Center (Nashua): Due to morbidity of autograft harvesting, the need for biologics for spinal fusions — especially MIS fusions — will continue to grow. As the technology and the science of stem cell, platelet-rich plasma and other autologous products advance, they will be used more commonly for non-fusion pain-relieving procedures and potentially to stop or reverse degeneration of intervertebral discs and facet joints.