hUC间充质干细胞(19#iSCLife®-OA)治疗骨关节炎的安全性/有效性

This is a random, 打开标签, 和平行对照实验. 所有患者均经过选择并签署同意书, 然后分为 3 团体. 医生收集患者的基本信息. All patients receive laboratory and image examination as baseline. 然后, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 周, 1, 2, 3, 6, 和 12 months after treatment, and do safety and efficacy evaluation.

Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, erythrocyte sedimentation rate, and tumor marker, ETC.

Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (增值服务) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (核磁共振成像) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.

分类: 干细胞疗法

国家统计局科学

合同研究组织

干细胞疗法