Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in WOMAC (Western Ontario and McMaster Universities)score
研究概览
简要总结
This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects.
详细描述
Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments seek to ameliorate pain or improve mobility. However, these treatments rarely modify the course of the disease.Recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. We designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 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 (visual analogue scale)
- •History of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage
排除标准
- •Any past history of neoplasia and primary hematological disease
- •Autoimmune disease or the medical history
- •Systemic bone or cartilage disorders
- •Acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- •Co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
- •Evidence of infection or fractures in or around the joint
- •Contraindication to bone marrow aspiration
- •Deviation from the axial axis (varus or valgus) greater than 12 degrees.
研究组 & 干预措施
Mesenchymal stem cells
Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells
干预措施: Bone marrow aspiration (Procedure)
结局指标
主要结局
Change in WOMAC (Western Ontario and McMaster Universities)score
时间窗: 3 months, 6 months, 9 months, 12 months
次要结局
- Change from baseline in cartilage thickness at 6 months by MRI(6 months)
- Knee pain relief (WOMAC and Lequesne scores)(3 months, 6 months, 12 months)
- Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)(12 months)
研究者
Alexandra Cristina Senegaglia
PhD
Pontifícia Universidade Católica do Paraná