Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) 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 mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4 radiographic OA severity.
详细描述
The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic UC-MSC-derived MTF administered to two arms osteoarthritis patients with grade 2, 3, or 4 radiographic OA severity (20 per arm). The first arm will receive an intra-articular injection of MTF into the knee joint under fluoroscopy. The second arm will receive 12 subcutaneous MTF injections, once per week.
For both arms, the primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of joint function improvement as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age >18 years and ability to understand the planned treatment.
- •Subjects 18 years of age or older with 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 women or cognitively impaired adults.
- •Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- •Inflammatory or post infectious 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.
- •Intra-articular 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 MTF
Trophic factors from umbilical cord mesenchymal stem cells administered intra-articularly.
干预措施: Trophic factors from umbilical cord mesenchymal stem cells (Biological)
Subcutaneous injection of MTF
Trophic factors from umbilical cord mesenchymal stem cells administered subcutaneously once per week for 12 weeks.
干预措施: Trophic factors from umbilical cord mesenchymal stem cells (Biological)
结局指标
主要结局
Number of participants with adverse events
时间窗: 12 months
次要结局
- Number of participants with a change in joint function from baseline WOMAC assessment at 12 months(12 months)
- Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system at 12 months(12 months)