University Hospitals Partners On Groundbreaking Live Joint Replacement Initiative

Innovations in Orthopaedics | Winter 2025

University Hospitals Cleveland Medical Center is collaborating on a transformational multi-institutional effort led by Case Western Reserve University to engineer, grow and commercialize “live” replacement joints to treat osteoarthritis (OA).

Ozan Akkus, PhD

The groundbreaking initiative is funded by the Advanced Research Projects Agency for Health (ARPA-H), a federal agency within the U.S. Department of Health and Human Services. The award is part of ARPA-H’s Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) program.

The project, entitled OMEGA: Orchestrating Multifaceted Engineering for Growing Artificial Joints, is spearheaded by the lead researcher Ozan Akkus, PhD, the Kent Hale Smith Professor of Engineering at Case Western Reserve University and Director of the Case School of Engineering’s Tissue Fabrication and Mechanobiology Lab. Other esteemed institutions participating in the project include Colorado State University, The Ohio State University, Rice University and Washington State University. Joining University Hospitals as clinical partners are the Louis Stokes Cleveland VA Medical Center and Massachusetts General Hospital.

“This is a moonshot project that has never been accomplished before,” Dr. Akkus says.

“Realizing such a challenging goal requires material scientists who can design a load-bearing structure populated with human cells that degrade at rates the body can replace.”

The endeavor seeks to develop a biological joint that will dissolve as the body remodels its own cartilage and bone within the joint space. Researchers are investigating both autologous- and donor-derived methods of cell collection for joint fabrication.

Jacob Calcei, MD, is a Co-Investigator of the study. Dr. Calcei is a board-certified, fellowship-trained orthopedic sports medicine physician and shoulder surgeon at University Hospitals and Assistant Professor at School of Medicine. He specializes in the treatment of acute injuries and chronic conditions of the shoulder, elbow, hip, knee and ankle.

James Voos, MD

“This project exemplifies the collaboration between University Hospitals and Case Western Reserve University and highlights the expertise that each of our institutions brings to this monumental endeavor to address osteoarthritis and the disability it causes,” says James Voos, MD, Chair, Department of Orthopaedics, the Jack and Mary Herrick Distinguished Chair in Orthopedics and Sports Medicine at University Hospitals, and Executive Director of the University Hospitals Haslam Sports Innovation Center.

According to the Centers for Disease Control and Prevention (CDC), OA is the most common degenerative joint disease, affecting 32.5 million people throughout the United States and 500 million people worldwide. Current treatments rely on pain management or arthroplasty.

Addressing the Growing Need for Knee Replacement

The OMEGA project is focused on knee joints because they represent the highest volume of surgeries to correct OA and account for the most significant arthritis-related healthcare impact.

According to the American College of Rheumatology, U.S. surgeons perform approximately 790,000 knee arthroplasties annually. With the procedure on the rise in younger patients, the lifetime risk of needing revision surgery is also increasing.

“This concept overcomes the limitations of traditional metal and plastic prosthetics by harnessing the body's ability to rebuild native tissue joints that could last a lifetime,” Dr. Voos says. “By utilizing human cells to create a framework that is biocompatible with bone and cartilage growth, we hope to offer patients a personalized, durable solution to relieve pain and restore mobility.”

A Five-year Plan to Commercialization

OMEGA’s goal is to scale the technology to be commercially available by 2029. Within five years, project leaders envision a clinical trial providing patients with biocompatible knee replacements that reverse OA damage and fully restore joint function. “We are tasked with engineering something that functions well and has the ability to be scaled, which means we can manufacture these devices at sufficiently high volumes and fabricate them at a price point that will be competitive with the current solutions,” Dr. Akkus says.

Funding will be conducted in two phases:

• Phase one:  $20.4 million to develop the “live” joint concept.
• Phase two: Pending milestone achievements, an additional $27.3 million could be awarded to validate safety and efficacy.

Researchers hope to establish a proof-of-concept device in years one and two, followed by testing in large animal models to begin seeking clearance from the U.S. Food and Drug Administration (FDA). Phase one clinical trials are slated to occur in the project’s final year and a half. “If everything goes to plan, University Hospitals will be the first clinical facility to test the device,” Dr. Akkus says.

For more information, contact Dr. Akkus at oxa@case.edu or Dr. Voos at James.Voos@UHhospitals.org.

Contributing Experts:
Ozan Akkus, PhD
Kent Hale Smith Professor of Engineering
Director,Tissue Fabrication and Mechanobiology Lab
Case School of Engineering
Case Western Reserve University

James Voos, MD
Chair, Department of Orthopedic Surgery
Executive Director
University Hospitals Haslam Sports Innovation Center
Jack and Mary Herrick Distinguished Chair, Orthopedics and Sports Medicine
University Hospitals Cleveland Medical Center

Charles H. Herndon Professor
Case Western Reserve University School of Medicine

Head Team Physician, Cleveland Browns
Medical Director, Cleveland Ballet

*Article reviewed and approved by ARPH-H Media 1/7/2025.