KCT0001577招募中未知
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 Patient with Chondral Defects in the Knee
MCTTBio0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Adult males and females aged over 19 and under 65
- •2) Defect size: 2 to 10 ? on the unilateral knee cartilage (up to 4 ? in volume)
- •3) Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage
- •4) The joint space is maintained over 50% relative to baseline
- •5) Patients with self-reliant behavior
- •6) Patients understand strict rehabilitation protocol and follow-up program and are willing to follow it.
- •7) Patients who consented to the clinical trial
排除标准
- •1) Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
- •2) kellgren and Lawrence grade = 3
- •3) Patients with arthritis associated with autoimmune diseases
- •4) Patients hypersensitive to bovine protein
- •5) Patients with Haemophilia or markedly reduced immune function
- •6) Patients hypersensitive to antibiotics like gentamicin
- •7) Patients with arterial bleeding and severe venous bleeding
- •8) Patients with other diseases including tumors except for cartilaginous defects of joints
- •9) Patients with a history of radiation treatment and chemotherapy within the past two years
- •10) Patients who are pregnant, nursing a baby or likely to get pregnant
- •11) Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration
- •12) The other cases of patients which doctors determine not participate in the trial
研究者
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