Case Western Reserve University is leading a group of research institutions from Ohio and the nation to grow replacement joints using patient cells to treat osteoarthritis, a condition where joint tissues break down over time, leading to pain and restricted mobility.
This research is the first of its kind in the nation and has the potential to dramatically change patients' lives, said CWRU's Dr. Ozan Akkus, the study's lead researcher.
The procedure, which will develop new cartilage using a tissue sample from the patient’s knee cartilage and marrow from the back side of the hip bone, "will revolutionize care, and osteoarthritis is not just simple limitation of mobility," he said. "It's a significant reduction in the quality of life of the people who are affected by it. It's a lifetime of pain."
This condition also "can be associated with addiction to pain relief medication” as typical treatments have focused on pain relief, often with prescription opioids, which have proven addictive, he added.
Treatment also typically involves surgery with knee and hip replacements using prosthetics, but the prosthetics typically last 20 years and need to be replaced, especially for younger recipients, Akkus said. He added that these replacements restrict mobility and the resulting reduced activity can cause additional health problems, including diabetes, cardiovascular issues and obesity.
As a result, people with this condition "suffer from it for a lifetime," he said.
More than one-third of Medicare recipients in Northeast Ohio have osteoarthritis, according to the Centers for Medicare and Medicaid Services, while more than 32 million Americans have the condition, the Centers for Disease Control and Prevention said.
Akkus is leading a coalition of 12 research institutions from Ohio and throughout the country in this effort. The project, known as “OMEGA: Orchestrating Multifaceted Engineering for Growing Artificial Joints," is a five-year, nearly $50 million effort backed by the U.S. Department of Health and Human Services. Other research institutions include University Hospitals, Louis Stokes Cleveland VA Medical Center, The Ohio State University, Colorado State University, Rice University and Washington State University.
The research goal is to have 40 patients using these live knee joints in five years and the treatment widely available by 2029, Akkus said. Those joints would be made up of biocompatible bone and cartilage from human cells meant to restore full, natural function to the joint. The research will be undertaken over five years.
The first two years will establish a prototype for animal studies, followed by testing the prototype for the next year and a half after that to ensure safety and effectiveness, Akkus said. If the U.S. Food and Drug Administration approves the animal trials, the last year and a half will involve testing the implants on a limited number of human patients.
Should those trials show that patients with the grown implants have comparable mobility to healthy joints, the research will move onto phase two clinical trials, Akkus said. That phase involves proving these grown implants are as effective as current metal polymer implants, which he said is the "current gold standard" for joint replacement. If the grown implants pass this test, researchers will work to make this new technology widely available to patients, while ensuring it is more affordable than current prosthetics, Akkus said.
