A Phase 1 interventional study of Allocetra in Temporomandibular Joint Osteoarthritis, sponsored by Dr. Amit Druyan. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Dr. Amit Druyan · Phase 1, Interventional, and Treatment
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)
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 6 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with Dr. Amit Druyan as lead sponsor.
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Exclusion Criteria:
Drug: Allocetra
Intra-articular injection of Allocetra performed once on Day 1 of the study
Number and severity of AEs, SAEs and injection reactions following treatment
Number and severity of AEs, SAEs and following treatment, and injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
Time frame: Day 0 to 12 month
Patient reported pain in the target TMJ
Change from baseline in patient reported pain Numerical Rating Scale (NRS) in the target TMJ at 3 months and 6 months following treatment.
Time frame: Screening to 6 months
Exploratory outcome: Assessment of TMJ function by examination
Number of patients with pain on palpation, clicking/crepitation, or mandibular mobility.
Time frame: Screening to 12 months
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