NCT06748651

Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Temporomandibular Joint Osteoarthritis (TMJ-OA)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Dr. Amit Druyan · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Temporomandibular Joint Osteoarthritis

Interventions

Type	Name	Description
DRUG	Allocetra	Intra-articular injection of Allocetra performed once on Day 1 of the study

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-02-07
• Completion: 2026-04-08
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: Israel