RecruitingPhase 1

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

Israel6 participantsStarted 2024-12-15

Plain-language 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)

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Diagnosed with temporomandibular OA in the target TMJ.
✓. Inflammatory findings by Magnetic Resonance Imaging (MRI).
✓. Acceptable blood workup results (CBC, electrolytes, kidney and liver function).

Exclusion criteria

✕. Prior intra-articular injection to the target TMJ within 3 months prior to treatment.
✕. Any significant injury or surgery to the target TMJ.
✕. Evidence of active local infection in the vicinity of the target TMJ or clinically significant active infection anywhere in the body.
✕. 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.

What they're measuring

Number and severity of AEs, SAEs and injection reactions following treatment

Timeframe: Day 0 to 12 month

Trial details

NCT IDNCT06748651

SponsorDr. Amit Druyan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-02-07

Contact for this trial

Amit Druyan, Dr.

972-3-5304413 Amit.Druyan@sheba.health.gov.il

View on ClinicalTrials.gov More Temporomandibular Joint Osteoarthritis trials