RecruitingPhase 1NCT06748651

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)


Sponsor

Dr. Amit Druyan

Enrollment

6 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing Allocetra — a cell-based therapy made from modified immune cells — injected directly into the jaw joint (temporomandibular joint, or TMJ) of patients with TMJ osteoarthritis whose pain and dysfunction have not responded adequately to conventional treatments. TMJ osteoarthritis causes progressive cartilage breakdown, joint pain, and jaw stiffness, and Allocetra works by reprogramming immune cells to reduce inflammation. Adults with a confirmed TMJ osteoarthritis diagnosis, inflammatory findings on MRI, and acceptable blood test results are eligible, while those with a recent joint injection, active infection, known neurological or rheumatic disease, or prior major TMJ surgery are excluded. Participants will receive a single intra-articular injection and will be followed with check-ups over one year to assess safety and early signs of benefit. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAllocetra

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


Locations(1)

Sheba Medical Center

Ramat Gan, Israel

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NCT06748651