Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in cartilage thickness at 12 months by MRI
研究概览
简要总结
Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage.
This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification
- •Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
排除标准
- •Has systemic bone or cartilage disorders
- •Has significant vascular impairment proximal to implant site
- •Has substantial joint destabilization including extensive osteophyte formation
- •Has substantial surface erosion of the weight-bearing articular cartilage
- •Evidence of infection or fractures in or around the joint
- •Contraindication to bone marrow aspiration
- •Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- •Any past history of neoplasia and primary hematological disease
- •Renal impairment indicated by serum creatinine greater than 200mM
- •Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU
- •Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
研究组 & 干预措施
Hyaluronic acid
干预措施: Hyaluronic Acid (Drug)
Bone marrow mesenchymal stem cells
Autologous bone marrow-derived mesenchymal stem cells
干预措施: Autologous bone marrow-derived mesenchymal stem cells (Biological)
结局指标
主要结局
Change from baseline in cartilage thickness at 12 months by MRI
时间窗: 12 months
次要结局
- IKDC Subjective Knee Evaluation Form (2000)(1 month, 3 months, 6 months, 9 months, 12 months)
- Visual Analog Score(1 month, 3 months, 6 months, 9 months, 12 months)
- Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)(12 months)
研究者
Dr Ya Mohammad Hassan Shukur
Senior Consultant Orthopedic Surgeon
National University of Malaysia