Using Allocetra to treat osteoarthritis in the jaw joint

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and initial effectiveness of Allocetra, an immunomodulatory cell-based therapy, administered via intra-articular injection in patients suffering from Temporomandibular Joint Osteoarthritis (TMJ-OA). The study focuses on individuals who have not adequately responded to conventional treatments and involves a single center, open-label design. Participants will receive a single treatment of Allocetra and will be monitored for up to one year to assess outcomes related to pain and joint function. The trial aims to address the underlying inflammatory processes associated with TMJ-OA.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sheba Medical Center
  Ramat Gan, Israel Recruiting

Study contacts

• Study coordinator: Amit Druyan, Dr.
• Email: Amit.Druyan@sheba.health.gov.il
• Phone: 972-3-5304413

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.