Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees: A Single-Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Methods: Ten patients with knee OA participated in this study. After being administered intra-articular SVF injections, their outcomes were evaluated using various questionnaires. MRI T2 mapping was conducted and compared before the intervention and 6 months after. All data underwent analysis using various tests.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 35 years.
- •Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2~
- •Persistent knee pain after nonsurgical treatment.
排除标准
- •Arthritis caused by other systemic or local immune diseases.
- •Patients who have undergone total knee replacement surgery.
- •Patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months.
- •Patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain.
- •Patients with severe heart problems and coagulation disorders.
- •Patients who have taken glucosamine within the previous month.
- •MRI exclusion conditions, including patients with a heart rhythm regulator who have received vascular surgery with a hemostatic clip and artificial heart valves.
研究组 & 干预措施
Stromal Vascular Fraction (SVF)
Ten patients with knee OA were administered intra-articular SVF injections.
干预措施: Intra-articular Stromal Vascular Fraction Injection (Procedure)
结局指标
主要结局
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Baseline and at 3 and 6 months post-intervention
range from 0-96, with higher scores indicating greater OA-related disability
Magnetic resonance imaging (MRI)
时间窗: Baseline and 6 months after the intervention
included T2 mapping
Visual Analogue Scale (VAS)
时间窗: Baseline and at 3 and 6 months post-intervention
range from 0-10, with higher scores indicating increased degree of pain
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline and at 3 and 6 months post-intervention
5 items, ranging from 0-96, with higher scores indicating worse life quality related to OA
次要结局
未报告次要终点
研究者
Shu-Hao Chang, MD
Visiting staff
Fu Jen Catholic University Hospital