NCT05060107Unknown1 期
A Phase I Study Aiming to Assess Safety and Efficacy of a Single Intra-articular Injection of MSC-derived Exosomes (CelliStem®OA-sEV) in Patients With Moderate Knee Osteoarthritis (ExoOA-1)
Francisco Espinoza0 个研究点目标入组 10 人开始时间: 2021年10月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 主要终点
- Adverse Event
研究概览
简要总结
The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic knee OA with VAS >50mm
- •Knee OA Kellgren-Lawrence grade II to III
- •Chondromalacia grade I to III
- •Stable joint
排除标准
- •Bilateral symptomatic knee OA
- •Local infection
- •Neoplasia
- •Joint replacement
- •Recent use of local steroids
- •BMI > 30
研究组 & 干预措施
Experimental group - sEVs
Experimental
Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose.
干预措施: Exosomes (sEVs) (Biological)
结局指标
主要结局
Adverse Event
时间窗: 12 months
Ocurrence of any adverse reactions within 12 months of treatment
次要结局
- Incidence of injection-related sinovitis according to effusion grading scale of knee joint(1 week)
- Percentage of responders(52 weeks)
- Incidence of injection-related pain according to VAS scale (0-100mm)(1 week)
- Pain reduction(52 weeks)
- Disability reduction(52 weeks)
研究者
Francisco Espinoza
Medical Chieff Officer, Regenero / C4C
Universidad de los Andes, Chile
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