Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect in osteoarthritis (OA) patients.
详细描述
The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will receive IV UC-MSC once per day for 3 consecutive days.
The primary objective of the trial is freedom from treatment associated adverse events at 3 and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline, and 3 and 12 months post treatment and will be quantified based on the Western Ontario and McMaster osteoarthritis index (WOMAC).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent by the subject.
- •Age greater than or equal to 18 years
- •Ability to understand the planned treatment.
- •Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
排除标准
- •Pregnant or lactating women
- •Women of childbearing potential unwilling to use two forms of contraception
- •Cognitively impaired adults.
- •Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- •Inflammatory or postinfectious arthritis.
- •More than 5 degrees of varus or valgus deformity.
- •Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
- •Intraarticular corticosteroid injection within the previous 3 months.
- •A major neurologic deficit.
- •Serious medical illness with a life expectancy of less than 1 year.
- •Prior admission for substance abuse
- •Body Mass Index (BMI) of 40 kg/m2 or greater
- •Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- •In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
研究组 & 干预措施
Intra-articular knee injection of UC-MSC
Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once
干预措施: Human umbilical cord tissue-derived mesenchymal stem cells (Biological)
IV injection of UC-MSC
Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days
干预措施: Human umbilical cord tissue-derived mesenchymal stem cells (Biological)
结局指标
主要结局
Number of participants with adverse events
时间窗: 3 months and 12 months
次要结局
- Number of participants with a change in joint function from baseline WOMAC assessment(3 months and 12 months)
- Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system(3 months and 12 months)