jRCT1080224103已完成3 期
Efficacy and safety of IK-01 for focal cartilage injury and osteochondritis dissecans,Phase 3 study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in IKDC score at 52 weeks after surgery
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Multicenter, Open-label, Randomized, Parallel-group Comparative Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 50age old under（—）
- 性别
- All
入选标准
- •(1) Patients with localized traumatic cartilage damage in the knee joint
- •(2) Patients with an IKDC score of less than 60 during screening
- •(3) Patients with an ICRS or Outerbridge classification of III or IV
- •(4) Patients with cartilage damage in the knee joint, with the area of cartilage damage judged to be 2 cm2 or more and 9 cm2 or less
- •(5) Patients who have not received treatment for MF
- •Sub-study,cohort 1
- •In addition to the main study criteria above, patients who meet the following criteria:
- •(1) Patients who received MF treatment more than one year ago at the time of obtaining consent, but still have cartilage damage, or patients who were deemed ineffective in the main study
- •Sub-study,cohort 2
- •(1) Patients with localized osteochondritis dissecans in the knee joint
- •(2) Patients with an IKDC score of less than 60 at the screening stage
- •(3) Patients with Nelson classification of III or IV on MRI images
- •(4) Patients with osteochondritis dissecans with cartilage damage area judged to be 2 cm2 or more and 9 cm2 or less
排除标准
- •(1) Patients with a history of treatment with human (autologous) cartilage-derived tissue regenerative medicine products or equivalent investigational products in the affected limb
- •(2) Patients with cartilage damage or osteochondritis dissecans in both knee joints
- •(3) Patients with knee osteoarthritis
- •(4) Patients with two or more cartilage damage sites in one knee joint, or patients with localized cartilage damage requiring treatment in both knee joints
- •(5) Patients with cartilage damage in the opposing joint surfaces
结局指标
主要结局
Change in IKDC score at 52 weeks after surgery
时间窗: 52 weeks after surgery
Change in IKDC score at 52 weeks after surgery (after IK-01 transplantation or MF) compared to preoperative values in patients with traumatic cartilage injury who did not undergo MF
次要结局
- Proportion of subjects with increase of 20 or more in IKDC score(52 weeks after surgery)
研究者
研究点 (1)
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