NCT03810521Unknown1 期
A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 30 and 75 years old
- •Knee-OA Kellgren Lawrence grade I to III
- •Pain density according to visual analogue scale superior or equal to 50 mm
- •Patelar condromalacia grade I to III
- •Stable joint with normal physical exploration
排除标准
- •Bilateral symptomatic disease
- •Local or systemic infection
- •Neoplasia
- •Immunosuppression state
- •Pregnancy
- •Anticoagulant therapy
- •Other types of arthritis
- •Symptomatic disease of hip and/or spine
- •Intra-articular infiltration with steroids in the last 3 months
- •Intra-articular infiltration with hyaluronic acid in the last 12 months
结局指标
主要结局
Incidence of adverse events
时间窗: 6 months
次要结局
- Change in WOMAC score(6 months)
- Change in VAS score(6 months)
- Changes in structural joint assessment by MRI(6 months)
研究者
Francisco Espinoza
Associate Professor
Universidad de los Andes, Chile
研究点 (2)
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