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

Last updated: December 26, 2024
Sponsor: Dr. Amit Druyan
Overall Status: Active - Recruiting

Phase

1

Condition

Osteoarthritis

Treatment

Allocetra

Clinical Study ID

NCT06748651
1400-24-SMC
  • Ages 18-60
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Prior intra-articular injection to the target TMJ within 3 months prior totreatment.

  2. Any significant injury or surgery to the target TMJ.

  3. Evidence of active local infection in the vicinity of the target TMJ or clinicallysignificant active infection anywhere in the body.

  4. Patients with a known neurological disease or rheumatic condition, a major medicalcondition that would affect quality of life and influence the results of the study,or other pain of unknown etiology.

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Allocetra
Phase: 1
Study Start date:
December 15, 2024
Estimated Completion Date:
April 08, 2026

Study 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.

Connect with a study center

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

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