Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.
详细描述
The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after 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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 55-70 years
- •Suffering from grade 2-3 OA was identified by two observers who differed accordingly Kellgren-Lawrence research scale
- •Absence of local or general infections
- •Haematological and biochemical analysis without significant changes being made cause contraindications
- •Patients can understand the nature of the study
- •Written informed consent is given to patients
排除标准
- •Patients are not willing to obey the study protocol
- •There are signs of infection or positive serology for HIV, hepatitis and syphilis
- •There is a history of cancer both in the family and yourself and the value of the examination tumour marker exceeds normal limits
- •There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results
- •Articular injection of the knee by any drug during the previous 3 months
- •Participate in any clinical trial or treatment 30 days before the study
- •Other conditions may, according to medical criteria, not support participation in this research
- •Patients are subordinates or low ranking members
研究组 & 干预措施
Arthroscopy + Booster
After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.
干预措施: Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome (Biological)
Arthroscopy + Pre-Conditioning
After arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.
干预措施: Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome (Biological)
Non Arthroscopy + Booster
Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.
干预措施: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome (Biological)
Non Arthroscopy + Pre-Conditioning
Without arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.
干预措施: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome (Biological)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: 6 month after injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Visual Analog Scale (VAS)
时间窗: 6 month after injection
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
时间窗: 1 month after injection
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
时间窗: 3 month after injection
To asses pain score, score 1(good)-10(worst)
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: 1 month after injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: 3 month after injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
次要结局
- Laboratory Asessment(3 months after injection)
- Magnetic Resonance Imaging (MRI) T2 mapping(6 month after injection)
- Laboratory Asessment(2 weeks after injection)
- Laboratory Asessment(1 month after injection)