Grant Award Details
- The primary objective of this project is to file an IND application for Hyaleon, which is a scaffold-free engineered neocartilage being developed for the treatment of defects in the temporal mandibular joint (TMJ) disc complex. Major activities include
- 1) tech transfer to a GMP facility for manufacture of Hyaleon, identifying tissue donors, harvesting, creating master and working cell banks, and the final Hyaleon product.
- 2) Manufacturing the Hyaleon analogous animal product and use in IND-enabling dose-response and long-term pivotal safety studies.
- 3) Developing the container and closure system.
- 4) Carrying out shipping and stability testing of Hyaleon.
- 5) Preparing and submitting the IND package.
- 6) Executing clinical trial start-up activities.
Grant Application Details
- Treatment of the TMJ disc complex
Therapeutic Candidate or Device
Tissue implant engineered using expanded, allogeneic chondroprogenitor cells
Defects of the temporomandibular joint disc complex
Though the mechanism has not been established, Hyaleon®️ may initially act as a load bearing structure that fills defects of the temporomandibular joint (TMJ) disc complex. The implant is slowly remodeled allowing for the original defect to be filled with regenerated tissue with properties akin to those of the native TMJ disc complex tissue.
Unmet Medical Need
Current TMJ treatments are inadequate. Non-surgical treatments provide temporary relief. Invasive treatments include removal of the TMJ disc complex and total joint replacement. Unmet medical needs exist in the treatment gap between palliative non-surgical and end-stage surgical approaches.
To submit IND application
Major Proposed Activities
- To develop GMP manufacturing for the product and test its shipping and stability
- To complete the IND-enabling preclinical studies
- To submit the IND and initiate clinical start-up activities
It is estimated that almost 7 million Californians suffer from pathologies of the jaw joint. These often result from defects of the TMJ disc complex, restricting jaw movement and causing pain, leading to difficulties in eating and speaking, severely reducing life quality. The proposed cell-based treatment, if successful, will provide significant benefit to California's TMJ patients, who currently have limited treatment options, by allowing regeneration of defects of the TMJ disc complex.