The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 主要终点
- Unexplained local and systemic symptoms or death
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).
详细描述
This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •K / L score of 2-3;
- •chronic knee pain;
- •no local or systemic infection;
- •without obvious contraindication of the joint puncture from hematology and biochemical tests;
- •informed consent.
排除标准
- •older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
- •HIV, hepatitis virus or syphilis virus infection or their serology is positive;
- •BMI index is greater than 30;
- •congenital or acquired knee deformity;
- •pregnant or lactating women;
- •tumor patients;
- •immunodeficiency patients;
- •intra-articular drug injection history within 3 months;
- •participating in other clinical trials;
- •other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.
研究组 & 干预措施
Mesenchymal Stem Cells from adipose
Mesenchymal Stem Cells from adipose will be injected.
干预措施: Mesenchymal Stem Cells from adipose (Biological)
hyaluronic acid
Hyaluronic acid will be injectied.
干预措施: Hyaluronic Acid (Biological)
结局指标
主要结局
Unexplained local and systemic symptoms or death
时间窗: 2 years
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
次要结局
- WOMAC score(2 years)
- VAS score(2 years)
研究者
yangziyi
arthritis clinic and research center
Peking University People's Hospital