A Randomized Control Clinical Trial to Evaluate the Efficacy of Intra-articular Injections of Mesenchymal Stem Cells Versus Hyaluronic Acid in Patients Affected by Osteoarthritis of the Knee
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic effect of adult autologous mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare to intra articular injection of Synvisc-One.
详细描述
Study Participants:
This study will involve patients affected by osteoarthritis who comply with the inclusion and exclusion criteria. 30 patients, between the age of 18 and <65, will be enrolled in the study and randomized into three groups to receive either an injection of MSCs, hyaluronic acid (HA) or no injection.
Type of Study: This is a randomized control study.
Treatment method: Each patient will randomly be assigned to one of the following treatment groups:
Group A) Mesenchymal stem cells (MSCs) Group B) Hyaluronic acid (HA) Group C) No 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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged between 18 and < 65
- •Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3
- •Patients on a pain level equal to or higher than 5 on a VAS scale of 10
排除标准
- •Previous cases of alcoholism or drug abuse
- •Pregnancy and breast-feeding
- •Serious pathologies such as carcinoma or autoimmune disease
- •Hypersensitivity toward Hyaluorinc Acid
- •Undergoing steroid-based systemic therapy or interrupted since less than 1 month
- •Significant hematologic diseases
- •Mechanical instability, ligamentous laxity/deficiency or gross deformity
研究组 & 干预措施
Autologous Mesenchymal Stem Cells Treatment (MSCs)
The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0.
T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
干预措施: Autologous Mesenchymal Stem Cells Treatment (MSCs) (Biological)
Hyaluronic acid (HA)
The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0.
T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
干预措施: Hyaluronic acid (HA) (Drug)
结局指标
主要结局
Knee Society Score
时间窗: One year
Clinical Questionnaire Assessment Tool. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor
Knee Society Function Score
时间窗: One year
Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
Magnetic resonance image (MRI) and X-ray assessment
时间窗: One year
Radiological assessment of the knee joint
次要结局
- Visual Analogic Scale (VAS) pain evaluation(One year)
- Western Ontario and McMaster Osteoarthritis Index (WOMAC)(One year)
- Health related quality of life score (HRQoL) - SF36(One year)
研究者
Dr. Ho Ki Wai
Clinical Professional Consultant
Chinese University of Hong Kong