Extension Study of FURESTEM-OA-Kit Injection Safety and Effectiveness in Knee Osteoarthritis Patients Previously Given Placebo in the K0701 Trial

What this Trial Is About

This research evaluates the safety and effectiveness of FURESTEM-OA-Kit injection in patients with knee osteoarthritis who previously received a placebo in the K0701 Phase 2a trial. It is an open-label, single-arm extension study conducted across multiple centers to further assess long-term outcomes. The study focuses on patients who have already participated in the earlier trial and follow-up study. Participants receive the FURESTEM-OA-Kit injection during this extension phase, with safety and efficacy being monitored over an extended period. The primary focus is on tracking adverse events of special interest for up to five years after treatment. Secondary measurements include changes in knee injury and osteoarthritis scores, pain assessments, and evaluations using X-rays and MRI imaging at multiple time points up to five years. Throughout the study, participants undergo regular assessments including clinical scoring systems such as KOOS, WOMAC, VAS, and IKDC at 3, 6, 12, 24, and 60 months post-treatment. Imaging evaluations like X-rays and MRI scans are performed at 12 and 24 months. Safety monitoring continues with long-term follow-up for adverse events. The total participation duration covers several years, providing comprehensive data on the treatments impact over time.

A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial