A Phase I/II, Randomized, Double-blind, Controlled Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients who experience an adverse event
研究概览
简要总结
Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.
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
- 18 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, Kellgren and Lawrence grade I, II, III on plain Rx films.
- •Chondromalacia patella grade I-III on knee MRI. With or without meniscal tear.
- •Stable knee and normal clinical exam of involved extremity
- •Written informed consent for patients.
排除标准
- •Bilateral symptomatic knee OA
- •Local or systemic infection.
- •Active neoplasia or immunosuppressive state
- •Pregnancy or Breastfeeding
- •Body Mass Index ≥ 30
- •Presence of Pacemaker or Lower extremity metal implant
- •Anticoagulant treatment other than aspirin.
- •Recent use of oral (previous month) or intra-articular (previous 3 months) corticosteroids
- •Concomitant inflammatory joint disease (cristal, connective tissue disease)
- •Valgus (>10o) or Varus (>5o) deformity of involved extremity
- •Condilar or Tibial plateau Generalized Bone Marrow edema on MRI
- •Significant symptomatic hip or spine disease
- •Significant abnormality in baseline lab tests
研究组 & 干预措施
Umbilical-cord mesenchymal stromal cells
Umbilical-cord mesenchymal stromal cells (UC-MSCs)
Allogeneic UC-MSCs 20 x 10e6 diluted on 3 mL of saline solution + 5% of Plasma AB
Arm 2a: single infusion group. UC-MSCs at 0 month
Arm 2b: double infusion group. UC-MSCs at 0 and 6 months
干预措施: umbilical-cord mesenchymal stromal cells (Biological)
Hyaluronic Acid (HA)
Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
Proportion of patients who experience an adverse event
时间窗: 12 months
according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)
次要结局
- Physical function improvement measured by WOMAC OA index(12 months)
- Change in pain density measured by Visual analogue scale (VAS)(12 months)
- QoL improvement measured by SF-36(12 months)
- Changes in WORMS scale measured by knee MRI(12 months)
研究者
Francisco Espinoza, MD
Alternative Investigator
Universidad de los Andes, Chile