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)

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)

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Joint Osteoarthritis
• Intervention / Treatment: Drug: Allocetra

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 Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amit Druyan, Dr.; Phone Number: 972-3-5304413; Email: Amit.Druyan@sheba.health.gov.il
• Study Contact Backup: Name: Tehila Biton; Phone Number: 972-3-5304413; Email: tehila.biton@sheba.health.gov.il

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Amit Druyan, MD; Phone Number: +972-52-3359665; Email: amit.druyan@sheba.health.gov.il
    • Contact: Amit Druyan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-articular Injection of Allocetra performed once on Day 1 of the study	Drug: Allocetra; Intra-articular injection of Allocetra performed once on Day 1 of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 to 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screening to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome: Assessment of TMJ function by examination	Number of patients with pain on palpation, clicking/crepitation, or mandibular mobility.	Screening to 12 months

Collaborators and Investigators

• Sponsor: Dr. Amit Druyan
• Collaborators: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): February 7, 2026
• Study Completion (Estimated): April 8, 2026

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; Cell therapy; TMJ; Macrophages; Temporomandibular; ALLOCETRA
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 1400-24-SMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No