DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

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13 BONEZONE • December 2016 | • Direct Metal Manufacturing Services • Anatomical Modeling • Manufacturing Services for Plastics • Surgical Simulation Visit us at AAOS March 15 – 17, 2017 in San Diego, Booth #5005 INDUSTRY UPDATE solution that extends the longevity of the joint and delays—or even eliminates—the need for a total replacement. The current research is focused on resurfacing the femoral head, Guilak says. The hope, though, is that eventually the technique will be applied to full resurfacing of both sides of the joint and then repeated for success in other joints, like knee and shoulder. Large animal studies are underway. The expectation is that they'll move to clinical studies in humans in the next three to five years, says Bradley Estes, Ph.D., Vice President of Research and Development at Cytex. Study of the anti-inflammatory or gene therapy combina- tions will have a longer regulatory process through FDA. Guilak describes the approach as such: "The gene that we used was for the inhibitor of a very potent inflammatory molecule called Interleukin-1, and it's involved in osteoarthritis and rheumatoid arthritis. It starts a lot of the inflammatory cascades. We put in a gene that inhibits Interleu- kin-1 called IO 1 receptor antagonist. It's a drug that's sold now as Kineret or Anakinra; it's approved for rheumatoid arthritis, but it's a naturally occurring molecule. It's a biologic molecule, so if you put the gene into the cell, it will produce that molecule. The other thing we did is put a part of the gene in so that we can turn the IO 1 receptor antagonist on and off, so it's not spewing out all the time in the joint. We can control, in what we call a tunable and inducible manner, how much is being produced. If we give the cells a small activating molecule, we just use doxycycline as an activator of this gene, and we can actually turn on the anti-inflammatory delivery, or we can turn it off by removing doxycycline." Cytex's largest barrier to commercialization, as for many small companies, is funding, says Estes. The team has spent nearly 15 years researching this technology and thus far the funding has been there. The research has been funded mainly through grants from entities like National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Aging of the National Institutes of Health, AO Foundation, Arthritis Foundation and the National Science Foundation. — Carolyn LaWell Scientists have regrown cartilage on a 3D woven scaffold shaped like a femoral head.

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