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
Study Type
OBSERVATIONAL
Enrollment
36
CHA University Bundang Medical Center
Seoul, South Korea
RECRUITINGKyung Hee University Hospital
Seoul, South Korea
NOT_YET_RECRUITINGIncidence of Adverse Event, AESI(Adverse Event of Special Interest)
Time frame: 5 years follow-up after treatment
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in 100-mm VAS
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Changes in International Knee Documentation Committee Scoring System (IKDC)
Time frame: Month 3, Month 6, Month 12, Month 24, Month 60 after treatment
Evaluation of International K&L grade(X-ray)
Time frame: Month 12, Month 24 after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
Time frame: Month 12, Month 24 after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
Time frame: Month 12, Month 24 after treatment
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