KCT0004420已完成未知
Randomized Double-blind Clinical Study of Intra articular injection of Catholic MASTER cell in Knee osteoarthritis
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
A single intra-articular injection of allogenic BM-MSCs provided satisfactory pain relief for patients with knee OA compared to control group at 9 months. Also, a comparison of T2 values from quantitative T2 MRI mapping for cartilage between two groups showed that IA BM-MSCs could have a preventive effect on OA progression at 12 months.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1.Age 20-80
- •2.diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for knee OA
- •3.symptomatic OA that lastede for at least 3 months before screening
- •4.Baseline Pain VAS =50 mm
- •5.treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due to OA pain
- •6.X-ray Kellgren-Lawrence grade 1~4
- •7.volauntarily enrolled with informed consent
- •8.no improvement with medical treatment for at least 3months
排除标准
- •1.disease in spine or lower extremities that can affect the outcome of index knee
- •2.surgery on lower extremities within 6month before injection or planned
- •3.joint symptoms that can affect the interpretation of the trial data or prevent the subject from enrollement including but not limited to symptomatic fracture, fibromyalgia, rheumatoid arthritis, reactive arthritis
- •4.steroid injection to the index knee within preivious 3months
- •5.hyaluronic acid injection to the index knee within preivious 6months
- •6.underwent cell therapy or gene therapy in the past
- •7.more than 3 times upper normal limit in one or more of the followings: serum creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or more than 3 times upper normal limit in two or more of the followings: bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •8.participation in a different clinical trial other than this within 4 weeks after initiation of the current study
- •9.use (reccuent use or addiction) of substances that can affect pain sensation such as narcotics
- •10.females of childbearing age who do not consent to effective contraceptive methods during the study period
- •11.pregnant or lactating woman
- •12.malignancy
- •13. considered to be inappropriate for the trial by investigators
研究者
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