Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)
Recruiting · NCT06748651 · Interventional (participants receive a specific treatment) · Lead sponsor: Dr. Amit Druyan
View the official record on ClinicalTrials.gov →Interventions studied
Allocetra
What this trial is about
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 take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Sheba Medical Center - Ramat Gan, Israel