Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection
研究概览
简要总结
This is a pilot study to assess safety and possible efficacy of Allocetra-OTS in end-stage knee osteoarthritis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older.
- •Diagnosed with end-stage knee osteoarthritis and are scheduled or offered surgery.
- •X-ray positive for knee osteoarthritis.
- •Pain and functional disability from osteoarthritis.
- •Acceptable blood workup results (CBC, electrolytes, kidney and liver function) from up to three months before treatment.
- •Mentally and physically able to fully comply with the study protocol.
- •Signed Informed Consent form.
排除标准
- •Evidence of active local infection in the vicinity of the knee joint.
- •Previous surgery of total or partial knee replacement in the injected knee.
- •Patients unable to provide informed consent due to language barrier or mental status.
- •Patients with a major medical condition that would affect quality of life and influence the results of the study.
- •Patients unwilling to be followed for the duration of the study.
- •Acute infection requiring intravenous antibiotics at the time of screening.
- •Other limb pain of unknown etiology.
- •Pain in the limb clinically assessed to arise from an origin which is not the affected knee joint.
- •Known neurological disease or rheumatic condition other than osteoarthritis.
- •Bleeding disorders.
- •Known cognitive disorder.
- •Concurrent participation in any other clinical study. Participation in an interventional investigational study within 30 days prior to enrollment.
- •Physician objection.
- •Positive pregnancy test.
研究组 & 干预措施
Allocetra-OTS
Two IA dose of Allocetra-OTS cells in suspension
干预措施: Allocetra-OTS (Drug)
结局指标
主要结局
Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection
时间窗: 6 months
The safety and tolerability endpoint evaluates the incidence and severity of complications following intraarticular injection of Allocetra-OTS: * Injection-related reactions occurring during Allocetra-OTS injection, including injection interruption/discontinuation. * Treatment-emergent adverse events following Allocetra-OTS injection. * Treatment-emergent serious adverse events. * Adverse events or serious adverse events related to the use of Allocetra-OTS as an intraarticular injection material. * Safety assessments beyond 1 month following injection will focus on events that are at least possibly related to Allocetra-OTS treatment.
次要结局
- SF-36 questionnaire response change along study period(6 month)
- Efficacy of Allocetra-OTS- Pain mitigation as measured by Visual Analog Scale tool.(6 months)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) response change along study period(6 month)
研究者
Amir Oron
Principal investigator
Kaplan Medical Center