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

Phase 1

Recruiting

• Conditions: Temporomandibular Joint Osteoarthritis
• Interventions: Drug: Allocetra

• Registration Number: NCT06748651
• Lead Sponsor: Dr. Amit Druyan

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study Start: 2024-12-15
• Study First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-02-07
• Study Completion: 2026-04-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-articular Injection of Allocetra performed once on Day 1 of the study	Allocetra	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel