Temporomandibular Joint Osteoarthritis
Conditions
Keywords
ALLOCETRA, Temporomandibular, Osteoarthritis, TMJ, Macrophages, Cell therapy
Brief summary
This study is a single center trial to assess the safety and initial efficacy of intra-articular administration of Allocetra to patients with Temporomandibular Joint Osteoarthritis (TMJ-OA)
Detailed description
The temporomandibular joint (TMJ) is a critical synovial joint enabling jaw movement. TMJ osteoarthritis results from factors such as disc dislocation, trauma, overuse, or developmental anomalies, affecting all joint structures, including cartilage, synovium, bone, and ligaments. Key pathological features include chondrocyte loss, extracellular matrix degradation, and subchondral bone remodeling. TMJ-OA progresses gradually through phases of activity and remission, ultimately leading to a burnout phase. Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. This study is a single center, open lable safety and initial efficacy trial to assess intra-articular administration of Allocetra in patients with TMJ-OA who have not responded sufficiently to conventional therapies. The study is comprised of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint. Patients will be followed for up to a year following treatment.
Interventions
DRUGAllocetra
Intra-articular injection of Allocetra performed once on Day 1 of the study
Sponsors
Sheba Medical Center
Dr. Amit Druyan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will consist of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint .
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with temporomandibular OA in the target TMJ. 2. Inflammatory findings by Magnetic Resonance Imaging (MRI). 3. Acceptable blood workup results (CBC, electrolytes, kidney and liver function).
Exclusion criteria
1. Prior intra-articular injection to the target TMJ within 3 months prior to treatment. 2. Any significant injury or surgery to the target TMJ. 3. Evidence of active local infection in the vicinity of the target TMJ or clinically significant active infection anywhere in the body. 4. Patients with a known neurological disease or rheumatic condition, a major medical condition that would affect quality of life and influence the results of the study, or other pain of unknown etiology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of AEs, SAEs and injection reactions following treatment | Day 0 to 12 month | Number and severity of AEs, SAEs and following treatment, and injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported pain in the target TMJ | Screening to 6 months | Change from baseline in patient reported pain Numerical Rating Scale (NRS) in the target TMJ at 3 months and 6 months following treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcome: Assessment of TMJ function by examination | Screening to 12 months | Number of patients with pain on palpation, clicking/crepitation, or mandibular mobility. |
Countries
Israel
Contacts
Primary ContactAmit Druyan, Dr.
Backup ContactTehila Biton
Outcome results
None listed