The purpose of this study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.
JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection. It primarily aims to improve joint function. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration. The subjects of this therapy were patients with K\&L grade 3 aged 20 or older. This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 260 patients will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 placebo control). After each patient completes 6-month visit (Visit 5) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
Chungbuk National University Hospital
Cheongju-si, South Korea
Yeungnam University Hospital
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline
Pain, stiffness, and physical function of the knee will be measured by the WOMAC score * Score range is 1. 0-20 for Pain 2. 0-8 for Stiffness 3. 0-68 for Pysical Function * Higher scores on the WOMAC indicate wors pain, stiffness, and functional limitations
Time frame: 12 weeks, 24 weeks
Change of Visual Analog Scale (VAS) scores from baseline
Pain of knee will be measured by the 100mm VAS -Score range is from 0-4mm(no pain) to 75-100mm(severe pain)
Time frame: 12 weeks, 24 weeks
WOMAC 3 subscale score
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Time frame: 12 weeks, 24 weeks
VAS score
Pain of knee will be measured by the 100mm Visual Analog Scale (VAS)
Time frame: 12 weeks, 24 weeks
KOOS
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS) -Score range is from 0(extreme symptoms) to 100(no symptoms)
Time frame: 12 weeks, 24 weeks
SF-36
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Time frame: 12 weeks, 24 weeks
IKDC
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chonbuk National University Hospital
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Kyunghee University Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University Health System
Seoul, South Korea
KyungHee University Gangdong Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
...and 3 more locations
Time frame: 12weeks, 24 weeks
Measuring of Kellgren-Lawrence grade
Measuring of Kellgren-Lawrence grade through X-ray
Time frame: 12 weeks, 24 weeks
Measuring of Femoro-tibial anatomical angle(FTA)
Measuring of FTA through X-ray
Time frame: 12 weeks, 24 weeks
Measuring of Hip-Knee-Ankle angle(HKA)
Measureing of HKA through X-ray
Time frame: 12 weeks, 24 weeks
Measuring of Joint Space Width
measuring Joint Space Width through X-ray
Time frame: 12 weeks, 24 weeks
MRI scan
MRI perform to measure Modified WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Time frame: 12 weeks, 24 weeks
Use of rescue medication
Frequency and total amount of rescue medication administration will be measured.
Time frame: 12 weeks, 24 weeks