The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients
In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side. The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection. It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
biological : Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml drug: saline solution
KyungHee University Gangdong Hospital
Seoul, South Korea
MRI scan
MRI perform to measure cartilage defect size change from baseline up to 27 weeks
Time frame: 24 months
MRI scan
MRI perform to measure cartilage defect size change from baseline up to 15 weeks
Time frame: 15, 27 weeks, 18, 24 months
WOMAC score
Change in WOMAC Total score from baseline up to 15, 27 weeks
Time frame: 15, 27 weeks, 18, 24 months
WOMAC sub-scale
Change in WOMAC sub-scale from baseline up to 15, 27 weeks
Time frame: 15, 27 weeks, 18, 24 months
Kellgren & Lawrence grade
Change in Kellgren \& Lawrence grade from baseline up to 15, 27 weeks
Time frame: 15, 27 weeks, 18, 24 months
EQ5D
Change in the score of EQ-5D from baseline up to 15, 27 weeks
Time frame: 15, 27 weeks, 18, 24 months
ROM
change from baseline in knee flexion Range of Motion(ROM) at 15,27 weeks by physical examination
Time frame: 15, 27 weeks, 18, 24 months
KOOS (Knee Injury & Osteoarthritis Outcome Score)
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 15, 27 weeks, 18, 24 months
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PGIC(Patient Global Impression of Change)
The percentage of subjects who were evaluated as improved at 15 weeks and 27 weeks in the patient global impression of change
Time frame: 15, 27 weeks, 18, 24 months
PSQI(Pittsburgh Sleep Quality Index)
Change in PSQI from baseline up to 15, 27 weeks
Time frame: 15, 27 weeks, 18, 24 months
Biomarkers
Change from baseline in Biomarkers up to 15, 27 weeks
Time frame: 15, 27 weeks, 18, 24 months
Incidence of adverse reactions and characteristics associated with investigational product
Time frame: 15, 27 weeks, 18, 24 months