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Summa Health System Opens Clinical Trial for Knee Replacement Patients with Resulting Inflammation and Pain

Date: 01.11.2011
Contact: Julie Uehara Sur Phone: (330) 375-7117

Contact: Julie Uehara Sur, Phone: (330) 375-7117, Email: ueharaj@summahealth.org

AKRON, Ohio, Jan. 11, 2011 – As the U.S. population ages, particularly with the baby boomers, more and more Americans are requiring joint replacements. Each year nearly one million Americans have a hip or knee replaced. While the vast majority of these procedures are successful, some patients end up with a chronically painful joint as a result of a cellular response to the prosthetic implant.

This often debilitating condition causes swelling and redness in the area around the artificial joint and can hinder a patient's ability to move or stand. This happens because, over time, cells in the tissue and bone near the implant become inflamed and begin to resorb and weaken the bone, which ultimately results in the loosening of the implant and may create the need for a revision surgery.

With few options for treatment, researchers in Summa Health System's Walter A. Hoyt, Jr. Musculoskeletal Laboratory recently opened a clinical trial that has been reviewed by the FDA for these symptomatic implant patients to test the usage of an internally developed oral medication known as Apatone®B. "The trial will evaluate Apatone-B's ability to control inflammation and improve the outcomes of patients who have undergone knee replacements and have since developed a reaction to the artificial joint or the microscopic wear debris produced by the implant," said Deborah Neal, the clinical trial coordinator.

In the Hoyt lab, researchers have been evaluating Apatone-B's ability to target the cells producing inflammatory proteins and shut down the mechanism that controls inflammation and bone breakdown. "Suppressing the inflammatory signals sent by these cells would help them grow more normally in the presence of a joint implant, reducing discomfort and preventing additional bone loss," said Mark Kovacik, a clinical trial research investigator. The goal is for Apatone-B to relieve the reactive condition and possibly extend the life of the artificial joint.

Preliminary analytical tests have shown that in cells exposed to prosthetic wear debris, a single dose of Apatone-B reduced the key inflammatory material by approximately 30 percent. Similarly, the subsequent cellular release of inflammatory signaling chemicals by these exposed cells was reduced by half, when compared to untreated cells.

"I'm excited about the potential outcomes for this patient group," said Thomas F. Bear, M.D., and orthopaedic surgeon with the Crystal Clinic Orthopaedic Center who is directing the study. "Our initial lab investigations were very encouraging and, if the results from this clinical trial are what we're expecting, there could be an enormous impact on the health and well-being of many people suffering from painful joint replacements."

Currently in progress, the clinical trial intends to enroll orthopaedic implant patients who have developed inflammation and discomfort in their replaced knee joint that is not due to infection. Half of the enrollees will be given a daily dose of oral Apatone-B and half will receive an oral placebo throughout the course of 13 weeks. Blood specimens and samples of synovial fluid surrounding the joints will be taken at the beginning of the trial and the end to compare the level of inflammation and bone loss to assess Apatone-B's effect.

What is Apatone®B?
Having a B designation for bone indications, Apatone-B is a lower concentrated combination of Vitamin-C and Vitamin-K3 that work together to target inflammation as a means of fighting disease and regulating abnormal cell activity. Any cell that produces the proteins associated with inflammation is targeted by the drug, while healthy tissue is spared.

The basis for this is that Apatone-B resembles glucose, the primary source of energy for cellular activity. By exploiting the increased uptake of glucose by inflamed cells, Apatone-B can selectively enter and treat only inflamed cells. Once retained by the cell, Apatone-B uses a double-barrel attack: first as an anti-oxidant to reduce free radicals and secondly as an anti-inflammatory agent by reducing a prominent inflammatory factor linked to the break-down of bone.

System-Wide Collaboration
Originally developed at a much higher concentration to help fight cancer, Apatone® works to selectively lower the level of compounds in tumor cells that protect against chemotherapy, thus weakening the cancer cells and making them more susceptible to treatment. Essentially, it primes tumor cells to more easily be killed by chemotherapy and radiation.

"Expanding Apatone's application from cancer to bone was the result of Summa's internal mechanism for promoting and disseminating information about research throughout the organization," said Steven P. Schmidt, Ph.D., vice president of Clinical Research & Innovation at Summa. "Our bimonthly Community of Research luncheons give Summa researchers a venue for presenting their work in front of other investigators and physician colleagues, fueling the potential for greater research collaborations."

A little more than two years ago, the Hoyt lab's scientific director, Michael Askew, Ph.D., was in attendance at the luncheon where James Jamison, Ph.D., director of the Apatone Development Center at Summa, presented his work on Apatone. Dr. Askew and other researchers from the Hoyt lab realized that Dr. Jamison and his group were working on the same cell material that orthopaedic researchers were studying in the hopes of finding a way to better control inflammation.

The difference was researchers in the Hoyt lab were looking to grow cells in spite of the presence of irritating metal particles, whereas Dr. Jamison and his colleagues were manipulating the same factor as a means of killing cancer cells.

What has ensued since the luncheon is an ongoing collaboration and sharing of information among researchers that benefits both cancer and orthopaedic disciplines. "The collaboration between the laboratories is allowing us to create something that is bigger than any of us could have achieved on our own," added Dr. Askew.

For more information about the Department of Orthopaedics and their activities, please call 330-379-5661.

About Summa Health System
Summa Health System is one of the largest integrated delivery systems in Ohio. Encompassing a network of hospitals, community health centers, a health plan, a physician-hospital organization, a multi-specialty physician organization, research and multiple foundations, Summa is nationally renowned for excellence in patient care and for exceptional approaches to healthcare delivery. Summa's clinical services are consistently recognized by HealthGrades, U.S. News and World Report, Thomson Reuters and The Leapfrog Group. Summa also is a founding partner of the Austen BioInnovation Institute in Akron. For more information, visit www.summahealth.org.

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