Spinal biologics have immense potential for the future of healing. Surgeons and scientists are working together to build upon the developed over the past decade and advance treatment for patients in the future.
The materials on the forefront of biologic research in the spine arena include:
• Mesenchymal stem cells
• Bone marrow aspirates
• Bone morphogenic proteins
• Demineralized bone matrices
"The mesenchymal stem cells come in various concentrated forms, through a few different innovative and interesting preparations," says Amir Vokshoor, MD, a board-certified neurological spinal surgeon with DISC Sports & Spine Center in Marina del Rey, Calif. "Bone marrow aspirate can be obtained from the vertebral body or from iliac crest to enhance fusion. In addition, bone morphogenic protein comes in a synthetic form along with a variety of demineralized bone matrices, containing osteoinductive and osteoconductive property."
Recombinant bone morphogenic protein-2 has been a primary biologic over the past decade, but increased scrutiny on complication rates and biologic reaction — coupled with cost concerns — decreased use among spine surgeons in the United States.
"There will be more research to [understand] the actual long term side effects [of rhBMP-2]," says Dr. Vokshoor. "I think it's used in more limited cases due to its cost and its side effects. It's being used in revision surgery or in cases with a high risk of failure."
Device companies and surgeon researchers are teaming up on new and exciting innovations, including trying to make live mesenchymal stem cells be higher in quantity and then potency in many of the bony substitute products. Dr. Vokshoor also considers a variety of growth factors, such as BMPs, that are exciting and new in research relativity.
"Surface coating of the implant is also something that's been going on for a little while but more people are trying to come up with ways to make the metallic or carbon fiber on the implant be coated with material that can help the bony surfaces [with] rapid healing," says Dr. Vokshoor. "Also, there are a variety of products that are trying to enhance nerve healing and they are quite experimental. There's research in growth factors as well as extracellular matrix of the spinal nerve and spinal cord as well as the use of carbon nanotubes in conducting nerve signals across injured segments of the spinal cord, which is very exciting."
However, there are several challenges researchers and developers face to bringing their new products to the market. Cost is a huge factor — both from product development and provider side — and companies must prove their devices will benefit patient outcomes.
"The cost of bringing a product from initial phase in biologics to actual commercialization and clinical use, especially in the United States, is astronomical and justifiably so," says Dr. Vokshoor. "The FDA has a lot of steps that people have to go through to test the product out so the mere cost of that research is pretty significant."
Another challenge is finding a good application of the scientific principles and unbiased statistical analysis for some of the initial trial testing in biologics, Dr. Vokshoor says. "I think that remains a challenge as well for successful biologic agents to make it to the market to be clinically beneficial."
The biggest opportunities for bringing innovation to the future spine market include:
• Less invasive use of the patient's own cells
• Mixed allograft and autograft with mesenchymal stem cells
• Disc regeneration
• Nucleus pulposus regeneration of the nerves through a combination of synthetic scaffolds such as carbon nanotubesmixed with stem cells or growth factors
More Articles on Spine Surgeons:
10 Spine Procedure Coverage & Reimbursement Updates
Minimally Invasive vs. Open Spine Surgery: Where the Field is Headed
11 Spine Devices Receive FDA 510(k) Clearance in February