Treatment of the TMJ disc complex
Grant Award Details
Grant Type:
Grant Number:
CLIN1-14764
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$6,000,000
Status:
Active
Grant Application Details
Application Title:
Treatment of the TMJ disc complex
Public Abstract:
Therapeutic Candidate or Device
Tissue implant engineered using expanded, allogeneic chondroprogenitor cells
Indication
Defects of the temporomandibular joint disc complex
Therapeutic Mechanism
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.
Project Objective
To submit IND application
Major Proposed Activities
Tissue implant engineered using expanded, allogeneic chondroprogenitor cells
Indication
Defects of the temporomandibular joint disc complex
Therapeutic Mechanism
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.
Project Objective
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
Statement of Benefit to California:
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.
