This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase I trial (NCT04037345 ) will be followed-up until 60 months.
The subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)
Seoul national University Hospital
Seoul, Jongno-gu, South Korea
RECRUITINGChange of total score in WOMAC (Western Ontario and McMaster University)
Comparing WOMAC total score changes with baseline scores of SMUP-IA-01 phase I trial and scores of f/u study at 12 months, 24 months, 36 months, 48 months and 60months after treatment (score range 0-96, higher score represent worse symptoms).
Time frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in WOMAC three subscales (Pain, stiffness, physical function)
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Time frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in 100 mm VAS (Visual Analogue Scale)
The score ranges from "0" or no pain to "100" very severe pain
Time frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in IKDC(International Knee Documentation Committee)
The scores for each category are summed up and divided into 87, which is the maximum score possible, and then is evaluated by converting it into a scale of 100 points. Higher score indicates better function and less symptoms for the knee.
Time frame: Month 12, 24, 36, 48 and 60 after treatment
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
For structural and tissue evaluation of knee, MRI image of detailed knee parts are graded from min. 0 to max. 6. Lower number indicate normal status
Time frame: Month 12 and 24 after treatment
Change in K&L(Kellgren-Lawrence) grade
The K \& L grade is 0 to 4 Grade, which means that the higher the grade, the greater the joint damage and the stenosis of the joint
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Time frame: Month 12 and 24 after treatment
Change in joint space width
Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography
Time frame: Month 12 and 24 after treatment
Change in mechanical axis, anatomical axis
The degree of deformation of the lower half of the body is measured by measuring the angles of the mechanical axis and the anatomical axis with respect to the vertical axis. Mechanical axis: A line connecting the femoral head center point and the ankle joint center point. Anatomical axis: The middiaphyseal line of the femur and tibia
Time frame: Month 12 and 24 after treatment
Rate of surgery to treat application site after treatment of SMUP-IA-01
Rate of surgery to treat application site after treatment of SMUP-IA-01
Time frame: Month 6, 12, 24, 36, 48 and 60 after treatment
Changes in biomarker
Comparing biomarker changes with baseline of SMUP-IA-01 phase I trial and scores of f/u study at 12 months after treatment. urine C-terminal cross-linking telopeptides of collagen type II (CTX II), serum cartilage oligomeric matrix protein (COMP), serum matrix metalloproteinase-3 (MMP-3)
Time frame: Month 12 after treatment