Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Recording of Adverse Events and Serious Adverse Events
研究概览
简要总结
Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.
详细描述
Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who understand and sign the consent form for this study.
- •Age: 40-70, males and females.
- •Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.
- •Patients who can't treat with traditional medication and need a arthroplasty.
- •Duration of pain over Grade 4(11-point numeric scale)> 4 months.
排除标准
- •Women who are pregnant or breast feeding or planning to become pregnant during the study.
- •Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study.
- •History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
- •Treatment with intra-articular injection therapy within 2 months prior to screen.
- •Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.
- •Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
- •Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
- •Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II).
- •Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
研究组 & 干预措施
Mesenchymal stem cells low-dose group
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.
干预措施: Mesenchymal stem cells low-dose group (Biological)
Mesenchymal stem cells mid-dose group
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
干预措施: Mesenchymal stem cells mid-dose group (Biological)
Mesenchymal stem cells high-dose group
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
干预措施: Mesenchymal stem cells high-dose group (Biological)
结局指标
主要结局
Recording of Adverse Events and Serious Adverse Events
时间窗: 12 weeks
Electrocardiogram
时间窗: 9 weeks
Vital signs
时间窗: 9 weeks
Physical examination
时间窗: 9 weeks
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)
时间窗: 24 months
Laboratory tests
时间窗: 9 weeks
Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests
次要结局
- SF-36(24 months)
- NRS-11(24 months)
- The volume of articular cartilage(24 months)