Using Allocetra to treat osteoarthritis in the jaw joint
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Temporomandibular Joint Osteoarthritis (TMJ-OA)
This study is testing a new treatment called Allocetra to see if it can help people with jaw joint osteoarthritis who haven't found relief from other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT06748651 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with TMJ-OA who exhibit inflammatory findings on MRI and have not responded to standard therapies.
Not a fit: Patients with recent intra-articular injections, significant TMJ injuries, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief and improved function for patients suffering from TMJ-OA.
How similar studies have performed: While the use of Allocetra is a novel approach, similar immunomodulatory therapies have shown promise in other joint conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ramat Gan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.