A Phase IIb, Prospective, Multicentre, Double-blind, Triple-arm, Randomized Versus Placebo Trial, to Assess the Efficacy of a Single Injection of Either 2 or 10 x 106 Autologous Adipose Derived Mesenchymal Stromal Cells (ASC) in the Treatment of Mild to Moderate Osteoarthritis (OA) of the Knee, Active and Unresponsive to Conservative Therapy for at Least 12 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Improvement of pain or physical function
研究概览
简要总结
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.
The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.
This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR)
- •Must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month
- •NSAID washout of at least 2 days before screening/baseline
排除标准
- •Previous treatments acting on cartilage or bone metabolism
- •Received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
- •Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
- •Kellgren-Lawrence Grade 1 or 4 in the index knee on any incidences.
- •Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
- •History of joint replacement of the knee or hip within the previous 12 months
研究组 & 干预措施
10x106 ASC intra-articular injection
Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
干预措施: Injection (10x106 ASC/5ml). (Biological)
Placebo
0.5% glucose in saline with 4.5% albumin
干预措施: Placebo (Other)
2x106 ASC intra-articular injection
Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
干预措施: Injection (2x106 ASC/5ml). (Biological)
结局指标
主要结局
Improvement of pain or physical function
时间窗: Month 6
evaluate the efficacy of ASC in mild to moderate knee OA (KL 2-3) based on increase in the number of "strict" responders defined by improvements from baseline in WOMAC pain or physical function subscores 50% with absolute changes 20 mm at 6 month, compared to placebo
次要结局
- Disability (WOMAC)(Months 1, 3, 6, 12 and 24)
- painkillers consumption(Months 1, 3, 6, 12 and 24)
- Disability (KOOS)(Months 1, 3, 6, 12 and 24)
- Disability (SAS)(Months 1, 3, 6, 12 and 24)
- Change in Quality of life(Months 1, 3, 6, 12 and 24)
- Structural changes (X-Ray)(Months 12 and 24)
- Structural changes (MRI)(Months 12 and 24)