Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Safety as Measured by Adverse Events
研究概览
简要总结
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.
详细描述
This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •voluntarily provided written Informed Consent
- •ages 20-70
- •male or female
- •grades I-III radiologically documented OA of one or both knees
- •American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
- •knee pain graded as greater than 3 out of 10 on screening questionnaire
- •able to speak, read and understand English -
排除标准
- •patient parameters falling outside of the inclusion criteria
- •current oral or parenteral steroid or blood thinner use
- •hyaluronic acid-based injection to the affected knee joint within the previous six months
- •corticosteroid injection to the affected knee joint within the previous three months
- •end stage (Grade IV) OA
结局指标
主要结局
Safety as Measured by Adverse Events
时间窗: Entire Study (1 year)
Adverse Events were recorded during the entirety of the study.
次要结局
- Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).(baseline to 3 months)
- Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Baseline to 1 year)
- Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion(Baseline to 3 months)
- Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain(Baseline to 1 year)
研究者
Peter B. Fodor MD
Peter B. Fodor, M.D.
Fodor, Peter B, M.D.