JPRN-jRCT2053220084招募中2 期
An open-label, multi-center exploratory study to investigate the efficacy and safety of autologous chondrocyte processed product (IK-01) for knee osteoarthritis
Otsuka Koji0 个研究点目标入组 10 人开始时间: 2022年9月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •Patients who have provided written informed consent using an IRB-approved explanation/consent form
- •- Patients aged 20 to less than 75 years at the time of informed consent
- •- Patients diagnosed with knee osteoarthritis according to the ACR classification criteria for knee osteoarthritis (clinical findings and X-ray imaging findings) during the screening period
- •- Patients diagnosed with knee osteoarthritis of Kellgren-Lawrence grade 2 or 3 on standing frontal X-ray findings during the screening period
排除标准
- •- Patients have multiple arthropathies in the lower extremities
- •- Patients with a history of or need to undergo surgery such as knee meniscectomy or suturing at the time of informed consent. However, if there is a history of meniscal resection or suturing, patients who have passed a certain period (8 weeks or more) after surgery can be enrolled
- •- Patients with a history of or need surgery such as ligament reconstruction for ligament damage of the evaluation target knee at the time of informed consent. However, patients who have passed a certain period (8 weeks or more) after surgery can be enrolled
- •- Patients who are judged to be inappropriate by the principal investigator or sub investigator
研究者
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