A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Treatment emergent adverse events
研究概览
简要总结
This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).
详细描述
Osteoarthritis (OA) of the first carpometacarpal (CMC) joint, or basal joint of the thumb, is a common, painful, and debilitating disease. For patients whose symptoms persist despite conservative therapies and rehabilitation strategies, surgery remains the last-resort treatment.
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 safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint (basal thumb joint) who have not responded sufficiently to conventional therapies.
The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses, followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible for this clinical study must fulfill all of the following:
- •Age 40 years or older.
- •Patients with OA of the first CMC joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications.
- •Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).
- •X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.
- •Blood tests from up to three months before treatment within protocol-defined limits.
排除标准
- •Subjects not eligible for this study include those that have any of the following:
- •Any significant injury, fracture, surgery, active local infection, deformity, severe Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand.
- •History of chondrocalcinosis in the target joint, concomitant rheumatic disease.
- •Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit.
- •Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
- •Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).
- •Secondary OA such as gout, hemochromatosis, rheumatoid/psoriatic arthritis.
- •Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.
- •For women of childbearing potential, a positive pregnancy test.
研究组 & 干预措施
Randomization phase - Placebo
Injection of placebo to the 1st CMC joint in the target thumb.
干预措施: Placebo (Other)
Safety run-in phase - Allocetra increasing dose
A dose escalation phase to characterize the safety of Allocetra injection to the 1st CMC joint in the target thumb in different doses and select the dose for the randomized phase.
干预措施: Allocetra - Safety run-in phase (Drug)
Randomization phase - Allocetra
Injection of Allocetra to the 1st CMC joint in the target thumb.
干预措施: Allocetra - Randomization phase (Drug)
结局指标
主要结局
Treatment emergent adverse events
时间窗: Day 0 to 6 months.
Treatment emergent adverse events following study treatment injection. Safety assessments beyond 4 weeks following injection will focus on events that are at least possibly related to study treatment.
Injection-related reactions
时间窗: Day 0 (Treatment visit).
Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
次要结局
- Thumb base pain - NRS(Screening day to 12 months.)
- Hand function - FIHOA(Day 0 to 12 months.)
- Key pinch and grip strength(Day 0 to 12 months.)
研究者
Amir Oron
MD
Kaplan Medical Center