Actively Recruiting
Evaluation of Allocetra Injection for Temporomandibular Joint Osteoarthritis Safety and Initial Effectiveness Study
Led by Dr. Amit Druyan · Updated on 2024-12-27
6
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
D
Dr. Amit Druyan
Lead Sponsor
S
Sheba Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and early effectiveness of Allocetra, an immunomodulatory cell-based therapy, for patients with Temporomandibular Joint Osteoarthritis (TMJ-OA). TMJ-OA affects the jaw joint and arises from issues like disc dislocation, trauma, overuse, or developmental problems, leading to damage in cartilage, bone, ligaments, and joint tissues. The condition progresses slowly through phases of activity and remission, eventually reaching a burnout stage. In this single-center Phase 1 trial, participants will receive a one-time injection of Allocetra directly into the affected temporomandibular joint. Allocetra consists of specially modified allogeneic peripheral blood mononuclear cells designed to be taken up by immune cells called macrophages and help restore joint homeostasis. The study includes two stages and focuses on patients who have not responded well to conventional treatments. Participants will be monitored for up to 12 months after the injection. Researchers will assess safety by tracking the number and severity of adverse events, serious adverse events, and any injection reactions. Evaluations include blood tests, MRI scans, and clinical assessments to understand the therapy's effects and participant response over time.
CONDITIONS
Official Title
Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with temporomandibular OA in the target TMJ
- Evidence of inflammation in the target TMJ seen on MRI
- Acceptable blood test results including CBC, electrolytes, kidney and liver function
You will not qualify if you...
- Received intra-articular injection to the target TMJ within 3 months before treatment
- History of significant injury or surgery to the target TMJ
- Active local infection near the target TMJ or active infection anywhere in the body
- Known neurological or rheumatic diseases, major medical conditions affecting quality of life, or unexplained pain
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
Research Team
A
Amit Druyan, Dr.
T
Tehila Biton
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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