Evaluation of Allocetra by Intra-articular Injection for the Treatment of Temporomandibular Joint Osteoarthritis (TMJ-OA)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number and severity of AEs, SAEs and injection reactions following treatment
研究概览
简要总结
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)
详细描述
The temporomandibular joint (TMJ) is a critical synovial joint enabling jaw movement. TMJ osteoarthritis results from factors such as disc dislocation, trauma, overuse, or developmental anomalies, affecting all joint structures, including cartilage, synovium, bone, and ligaments. Key pathological features include chondrocyte loss, extracellular matrix degradation, and subchondral bone remodeling. TMJ-OA progresses gradually through phases of activity and remission, ultimately leading to a burnout phase.
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This study is a single center, open lable safety and initial efficacy trial to assess intra-articular administration of Allocetra in patients with TMJ-OA who have not responded sufficiently to conventional therapies.
The study is comprised of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint.
Patients will be followed for up to a year following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Intra-articular Injection of Allocetra performed once on Day 1 of the study
干预措施: Allocetra (Drug)
结局指标
主要结局
Number and severity of AEs, SAEs and injection reactions following treatment
时间窗: Day 0 to 12 month
Number and severity of AEs, SAEs and following treatment, and injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
次要结局
- Patient reported pain in the target TMJ(Screening to 6 months)
研究者
Dr. Amit Druyan
Principal Investigator
Sheba Medical Center