The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.
JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues 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 improve pain and joint function, and secondary, to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration within six months. The subjects of this therapy were regenerative patients with K\&L grade 2\~4 aged 18 or older. JOINTSTEM is expected to be used in patients who have significantly damage cartilage due to its cartilage regeneration ability, in addition to its improvement of pain and joint performance. A;sp. Patients who had already undergone knee arthroplasty can delay their additional surgery with the use of JOINTSTEM. For dose who still have their own cartilage, arthroplasty is not an immediate treatment option, and osteoporosis patients who cannot undergo arthroplasty due to their advanced age can receive JOINTSTEM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Jointstem (Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml), 1 time injection
Saline solution (Sodium chloride 9mg/ml), 1 time injection
KyungHee University Gangdong Hospital
Seoul, South Korea
GangNam Severance Hospital
Seoul, South Korea
WOMAC score
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Time frame: 24 weeks
WOMAC 3 subscale
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Time frame: 24 weeks
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: 24 weeks
SF(Short Form)-36 Score
The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
Time frame: 24 weeks
Global assessment of disease activity
Change From Baseline in Patient's \& Physician's Global Assessment of Disease Activity Score at 12,24 weeks by 100mm VAS(Visual Analogue Scale)
Time frame: 24 weeks
Overall satisfaction
Patient's overall satisfaction on a 0-100mm VAS(Visual Analogue Scale)
Time frame: 24 weeks
X-ray
X-ray perform to measure with Kellgren-Lawrence grade
Time frame: 24 weeks
MRI scan
MRI perform to measure cartilage defect size change from baseline up to 24weeks
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Time frame: 24 weeks
Arthroscopy evaluation
Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 24 weeks after injection
Time frame: 24 weeks
Histological evaluation
Biopsy specimens subject to safranin-O staining and immunohistochemistry for type I and II collagen. Thickness of the articular cartilage before and after injection measure, and specimens evaluate with ICRS(International Cartilage Repair Society) II by a blind histopathologist.
Time frame: 24 weeks
VAS
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
Time frame: 24 weeks
IKDC
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Time frame: 24 weeks
ROM
change from baseline in knee flexion Range of Motion(ROM) at 12,24 weeks by physical examination
Time frame: 24 weeks
Quadriceps power
Change from baseline in quadriceps power at 12,24 weeks by physical examination
Time frame: 24 weeks
effusion
Change from baseline in 4-grade knee effusion at 12,24 weeks
Time frame: 24 weeks
Crepitus
Change from baseline in asymptomatic and symptomatic crepitus at 12,24 weeks by physical examination
Time frame: 24 weeks
Ligament laxity
Change from baseline in ligament laxity at 12,24 weeks by physical examination
Time frame: 24 weeks
Medial joint line tenderness
Change from baseline in 4-grade(none, mild, moderate, severe) medial joint line tenderness at 12,24 weeks by physical examination
Time frame: 24 weeks
Pes tenderness
Change from baseline in 4-grade(none, mild, moderate, severe) Pes tenderness at 12,24 weeks by physical examination
Time frame: 24 weeks