Irvine, Calif., May 1, 2023 — The California Institute for Regenerative Medicine has awarded $6 million to researchers in the Department of Biomedical Engineering at the University of California, Irvine to perform preclinical trial studies of Hyaleon®, an engineered neocartilage implant designed to treat defects of the temporomandibular joint.
Developed at UCI under the guidance of Kyriacos Athanasiou, UCI Distinguished Professor of biomedical engineering, Hyaleon® is the main product of Cartilage Inc., a UCI-based start-up company that will ultimately commercialize the innovation.
As many as a quarter of adults will suffer a TMJ pathology. Severity ranges from minor to debilitating, affecting in many cases sufferers’ ability to speak and chew. Up to 70 percent of problems involve displacement of the fibrocartilage TMJ disc.
Injections and other non-surgical treatments of TMJ injuries or pathologies have short-lived efficacy, according to Athanasiou. He said the most widely accepted surgery is removal of the TMJ disc and its attachments, but this approach can lead to diminished quality of life for patients.
“Total joint replacement is performed for end-stage cases, but this is considered to be a drastic step,” said Athanasiou, who also holds the title of Henry Samueli Chair in Engineering. “What has been needed is an approach that allows for the regeneration of the tissues of the TMJ disc complex without having to resort to total joint replacement, and that’s the gap that our Hyaleon® engineered neocartilage implant fills.”
Athanasiou said the healing effectiveness of the Hyaleon implant has been demonstrated in a series of statistically powered large-animal studies conducted by his group of tissue engineers, veterinarians, and surgeons.
The results the group achieved included:
- a more than four-time better defect closure of focal partial-thickness defects compared to controls;
- an achievement of focal full-thickness repair that was more than six times tougher, nine times more resilient, and three and a half times stronger than controls;
- and a complete filling of large full-thickness defects with regenerated tissue possessing up to 81 percent of native tissue properties, where controls remained unhealed.
“Hyaleon®, which is formed using chondroprogenitor stem cells and chondrocytes, is a mechanically robust engineered cartilage,” said Athanasiou.
The 30-month project will involve the development of the product’s manufacturing process, including the creation of working and master cell banks from human donors; completion of Investigational New Drug-enabling preclinical animal studies; development of a container and closure system to execute shipping and stability testing of the product; submission of an Investigational New Drug package to the U.S. Food and Drug Administration; and the execution of clinical trial start-up activities.
“This next phase will be intense and place a lot of demands on my research group, but we are prepared for the challenge,” said Athanasiou. “We thank CIRM, California’s stem cell agency, for funding our work to prepare Hyaleon® for clinical trials.”
Joining Athanasiou in this project are Jerry Hu, DELTAi principal development engineer; and Ryan Donahue and Wendy Brown, DELTAi translational fellows.
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