MedDataX Logo

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

NCT ID: NCT06748651

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2026-04-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Joint Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ALLOCETRA Temporomandibular Osteoarthritis TMJ Macrophages Cell therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Allocetra

Intervention Type DRUG

Intra-articular injection of Allocetra performed once on Day 1 of the study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allocetra

Intra-articular injection of Allocetra performed once on Day 1 of the study

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Dr. Amit Druyan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Amit Druyan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amit Druyan, Dr.

Role: CONTACT

Phone: 972-3-5304413

Email: [email protected]

Tehila Biton

Role: CONTACT

Phone: 972-3-5304413

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Amit Druyan, MD

Role: primary

Amit Druyan, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1400-24-SMC

Identifier Type: -

Identifier Source: org_study_id