Clinical trial NCT06748651: Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)
Official title: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Temporomandibular Joint Osteoarthritis (TMJ-OA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Temporomandibular Joint Osteoarthritis
Keywords: ALLOCETRA
Temporomandibular
Osteoarthritis
TMJ
Macrophages
Cell therapy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Sheba Medical Center
First posted: 2024-12-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 .
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number and severity of AEs, SAEs and injection reactions following treatment
timeFrame: Day 0 to 12 month
Secondary outcomes:
measure: Patient reported pain in the target TMJ
timeFrame: Screening to 6 months
Other outcomes:
measure: Exploratory outcome: Assessment of TMJ function by examination
timeFrame: Screening to 12 months
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: