Here six spine specialists discuss the role of biologics in the future of the spinal care industry.
Ask Spine Surgeons is a weekly series of questions posed to spine surgeons around the country about clinical, business and policy issues affecting spine care. We invite all spine surgeon and specialist responses.
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Please send responses to Anuja Vaidya at avaidya@beckershealthcare.com by Wednesday, Oct. 12, at 5 p.m. CST.
Question: How will biologics grow over the next five years?
Brian R. Gantwerker, MD, The Craniospinal Center of Los Angeles: I believe biologics will actually stagnate or evolve very slowly. Silicon-based technologies sound interesting, but I think most patients would not like the idea of "glass" being put in their spines. Also, the efforts of payers to classify standard cell-based biologics as stem cell therapy will thwart its ultimate growth. However, I think the use of biologics themselves will diminish, as more data supporting techniques such as arthroplasty become accepted and easier to apply in more advanced disease states.
J. Brian Gill, MD, MBA, Nebraska Spine Hospital, Omaha: Minimally invasive surgeries are fueling this growth as alternatives are sought for bone grafting materials to reduce operative time, pain, hospital stays, cost, etc. As the minimally invasive market grows, so will biologics.
Srdjan Mirkovic, MD, NorthShore Orthopaedic Institute, Evanston, Ill.: Interest in biologics is high but I anticipate the growth to be slow over the next five years, mainly due to it being such a complex field.
The possibilities of bone growth are exciting. Osteoinductive biologics research into bone morphogenetic proteins, stem cells, disc regeneration and gene therapy will continue to progress. But much research is yet to be done. The majority of the research has to advance well beyond the animal stage when determining dosage, delivery systems and efficacy. There are a lot of unanswered questions and this type of research is expensive. Advancements in these areas are filtered by cost and benefit of care.
Osteoconductive biologics are likely to continue to be used. Their efficacy, safety and cost compared to the safe and less expensive use of allograft remains to be determined. The use of a patient's own harvested bone will remain the gold standard for spinal fusions.
Over the next five years, it will be an exciting but challenging time with biologics in spine care. I anticipate real change in this area will come closer to 10 to 20 years from now.
Luga Podesta, MD, director, sports medicine, St. Charles Orthopedics, E. Setauket, N.Y.: Over the past 10 years, there has been significant increasing interest in cell-based therapies and biologic treatments including platelet-rich plasma and stem cells to treat sports-related and other musculoskeletal injuries involving soft tissue tendons, ligaments, muscle, bone and articular cartilage.
Advancement in cell, molecular and developmental biology have helped to discover the signaling molecules responsible for specific cell lineages — that is, muscle, tendon, ligament and articular cartilage — involved in tissue formation and regeneration.
Further research and acquired knowledge into how these particular biologic therapies, cell components and bioactive proteins participate and affect the tissue repair response will aid in the basic understanding of their desired mechanisms of action. The role of PRP, stem cell and other biologic cell-based treatments in sports medicine may signal a new era where athletic musculoskeletal and other orthopedic injuries are treated with growth factors, stem cells, bioactive proteins and tissue-specific cell lines. However, there remains a significant amount of work that needs to be done proving efficacy and safety data before these therapies become the standard of care.
Medhat Mikhael, MD, pain management specialist, medical director, Center for Spine Health at Orange Coast Memorial Medical Center, Fountain Valley, Calif.: Biologics will play a vital rule in the future of medicine. Researchers are working on production of about 900-plus medicines and vaccines to treat several diseases from autoimmune diseases and rheumatologic diseases to cancer. Examples of some of the biological products are the monoclonal antibodies, therapeutic vaccines, blood products, gene therapies and cell therapy. It is basically the future of medicine. The hope is that the changes in healthcare do not affect these researchers or the coverage of these products to the patients in a negative way.
Steve Yoon, MD, Director, orthobiologics & regenerative medicine, Kerlan-Jobe Orthopedic Clinic, Los Angeles: The use of biologics within all fields of medicine is growing at a rapid pace due to its potential for healing in addition to its possible anti-inflammatory and anti-scarring effects. Understanding the cellular and molecular pathways and how it pertains to clinical outcomes will be key in understanding how to use this material. The use of biologics will increase both in the clinical and operative setting as it may prevent patients from undergoing surgery, and when surgery is warranted, it could possibly improve surgical outcomes. It's here to stay and the knowledge base and momentum is growing each year.