Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
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
- 2
- 主要终点
- WOMAC(Western Ontario and McMaster Universities) Index
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with degenerative arthritis.
详细描述
degenerative arthritis is the most common type of arthritis. It is estimated that 26.9 million Americans 25 years old or older have clinical degenerative arthritis of some joints, with a higher percentage of affliction in the older population. Its clinical manifestations include joint pain and impairment to movement, and surrounding tissues are often affected with local inflammation. The etiology of degenerative arthritis is not completely understood; however, injury, age, and genetics have been considered among the risk factors.
Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage, with associated changes in bone. Cartilage has limited intrinsic healing and regenerative capacities.
Due to the increasing incidence of degenerative arthritis and the aging population coupled with inefficient therapeutic choices, novel cartilage repair strategies are in need.
The availability of large quantities of MSCs and their potential for ready chondrogenic differentiation after prolonged in vitro expansion have made MSCs the most hopeful candidate progenitor cell source for cartilage tissue engineering.
In the clinical study, mesenchymal stem cells will be isolated from adipose tissue and cultured, and administered into the cartilage tissue lesion by orthopedic surgery.
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
- 18 Years 至 75 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 :18-75, 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.
- •Patients whose lesion is 2~6 cm2 in size.
- •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 contain herbal medicine 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 orHIV-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). BMI estimated as mass (kg) / corporal surface (m2).
- •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.
结局指标
主要结局
WOMAC(Western Ontario and McMaster Universities) Index
时间窗: 24 weeks
Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.
Safety evaluation
时间窗: 24 weeks
To determine the overall safety of RNL-JointStem® carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.
次要结局
- KSCRS(Knee Society Clinical rating System)(24 weeks)
- VAS(11-point box visual analogue scale)(24 weeks)
- Magnetic Resonance Imaging(24 weeks)
- Histological evaluates(24 weeks)