Confirmatory study to investigate the efficacy and safety of autologous chondrocyte processed product (IK-01) for knee osteoarthritis

CynosBio, Inc.0 个研究点目标入组 54 人开始时间: 待定最近更新: 2025年2月20日

试验速览

暂无简介。

•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

•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 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 8 weeks or more after surgery can be enrolled
•Patients who are judged to be inappropriate by the principal investigator or sub investigator

WOMAC total score

时间窗: 52 weeks post-transplantation of IK-01 or post-treatment of Hyaluronic acid

Change from baseline

未报告次要终点

发起方

CynosBio, Inc.