Keck Medicine of USC has launched a clinical trial testing the safety and tolerability of a new investigational treatment and its potential effects on preventing cartilage deterioration in people with knee osteoarthritis, the most common form of the disease. The therapy, known as CX-011, is administered through a single injection into the knee joint.
Approximately 33 million Americans live with osteoarthritis, a progressive disease that breaks down the cartilage that cushions joints. The condition can cause chronic pain, stiffness and reduced mobility, making everyday activities increasingly difficult. Although existing treatments can relieve symptoms, they do not stop the disease from progressing, and some patients ultimately need joint replacement surgery.
"For decades, physicians have helped patients manage the pain of osteoarthritis but have never been able to stop the disease from progressing," said Jay R. Lieberman, MD, chief of USC Orthopaedic Surgery with Keck Medicine and chair of the Department of Orthopaedic Surgery with the Keck School of Medicine of USC, who is leading the clinical trial. "We hope to one day move beyond symptom management and toward preserving joint health for the patients we serve."
How CX-011 was developed
CX-011 was developed in the Department of Orthopaedic Surgery at the Keck School through research led by Denis Evseenko, MD, PhD, vice chair for research in orthopaedic surgery and a professor of orthopaedic surgery, stem cell research and regenerative medicine at the Keck School.
His team identified a series of molecular signals involving GP130, an immune system receptor that tell cells how to respond to inflammation. GP130 supports normal immune, cardiovascular and stem cell functions. However, in osteoarthritis, immune system signals can become overactive and contribute to further cartilage damage, creating a cycle of deterioration.
CX-011 was designed to interrupt this inflammation-related signaling without blocking GP130 entirely. In animal models of osteoarthritis, Evseenko's team observed signs of reduced joint pain, improved joint structure and function, cartilage regeneration and tissue healing after administering CX-011. These preclinical findings supported further evaluating CX-011 in a clinical trial.
Details of the clinical trial
Keck Medicine is the sole site conducting the randomized, double-blind, early-phase trial.
The primary goal of the trial is to evaluate the safety and tolerability of the investigational injection. Researchers will also use standardized questionnaires and MRI scans to collect information about participants' pain, physical function and cartilage health over the course of the trial.
Advancing biomedical discovery to clinical testing
The USC Office of Research and Innovation, through the Alfred E. Mann Institute (AMI), was instrumental in bringing Evseenko's pre-clinical findings into a potential therapy. The AMI helps develop promising biomedical discoveries for clinical use by providing venture funding, industry connections and strategic guidance, including support for researchers who form and grow companies to develop new technologies and treatments for patients.
As an academic health system, we bring scientists and physicians together to shape research around the needs of our patients. That collaboration, combined with the resources needed to move discoveries beyond the laboratory, allows us to rigorously evaluate emerging approaches that may expand patients' treatment options."
Jay R. Lieberman, MD, chief of USC Orthopaedic Surgery, Keck Medicine
A study spanning 118 countries reveals a divide in pain and aging