KCT0004966尚未招募未知
A Multi-Center, Active-Controlled, Open-Label, Phase ? Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation with CartiLife versus Microfracture for Patients with Knee Chondral Defects
Biosolutions0 个研究点目标入组 104 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1. subject who aged greater than 18 years, but less than 65 years
- •2. Subject who has a size of the relevant cartilage lesion greater than 2 ?, but less than 10 ? (total volume considering the depth should not exceed 4 ?.)
- •3. Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage. Subject with relatively healthy cartilage (ICRS Grade?~?) around the area of damaged cartilage
- •4. Subject who has KOOS pain value less than 55 at baseline
- •5. Subject with self-reliant behavior
- •6. Subject who agrees to follow recommended physical therapy including exercise conducted in the home
- •7. Subject who is able to provide informed consent and comply with study requirements
排除标准
- •1. Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
- •2. Subject with Kellgren and Lawrence grade ? or higher
- •3. Subject with arthritis associated with autoimmune disease
- •4. Subject who has a history of hypersensitivity to bovine protein or the composition of the drug
- •5. Subject who has a history of hypersensitivity to gentamicin
- •6. Subject with Hemophilia or markedly reduced immune function
- •7. Subject with arterial bleeding and severe venous bleeding
- •8. Subject with other diseases including tumors except for cartilaginous defects of joints
- •9. Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
- •10. Subject who is currently pregnant or nursing
- •11. Subject who participates in concurrent trials or in previous trial within 30days of signing in formed consent
- •12. Subject who had any medical condition that can hinder the efficacy or safety evaluation of the investigational drug or did not complete this study as investigator comment
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