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Recruiting Phase 1 NCT06748651

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

Trial Parameters

Condition Temporomandibular Joint Osteoarthritis
Sponsor Dr. Amit Druyan
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 6
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2024-12-15
Completion 2026-02-07
Interventions
Allocetra

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)

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.

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