This clinical trial is for patients who have been diagnosed with Kellgren-Lawrence (K\&L) Grade 2 or 3 knee osteoarthritis on radiographic examination. Only subjects who voluntarily agree to participate by filling out the written Informed Consent document will undergo screening for subject selection (inclusion/exclusion) criteria, at which time the severity of OA in each knee will be used to determined which knee will be treated (index knee - i.e., the more severely affected knee), and enroll in this study.
Patients who meet the inclusion/exclusion criteria will be randomly assigned at visit 2 to either of study group 1(low-dose), study group 2 (mid-dose) or active control group at 1:1:1 ratio. Patients will be administered with investigational product. Investigational product will be administered into the to-be-treated (index) knee one time within 7 days after randomization. All patients enrolled will be followed up a total of 6 times (1, 4, 8, 12, 24, and 52 weeks) for up to post-dose 12 months. The patients should visit the study facility according to the visit schedule, and will undergo safety evaluation (vital sign, laboratory test, etc.) and efficacy evaluation \[Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS), International Knee Documentation Committee (IKDC) subjective knee evaluation\].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
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 Sodium chloride
Seoul Nation University Bundang Hospital
Gyeonggi-do, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Korea University Anam Hospita
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score at post-dose 52 weeks from baseline
Total score is between 0 point (no symptoms) \~ 96 points (higher score representing worse symptoms).
Time frame: Baseline, 52 week
Change amount of WOMAC total score at post-dose 24 weeks from the baseline
Total score is between 0 point (no symptoms) \~ 96 points (higher score representing worse symptoms).
Time frame: Baseline, 24 week
Chage amount of WOMAC score by item (pain, stiffness, physical function) at post-dose 24 weeks and 52 weeks from the baseline
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: Baseline, 24 week, 52 week
Chage amount of 100-mm VAS((Visual Analogue Scale) at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks from the baseline
The score ranges from "0" or no pain to "100" very severe pain
Time frame: Baseline, 1 week, 4 week, 8 week, 12 week, 24 week, 52 week
Chage amount of IKDC(International Knee Documentation Committee) at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks from the baseline
IKDC subjective knee evaluation consists of three categories: symptoms, sports activities, and functions. For each category, there are 7 questions for symptoms, 2 questions for sports activities, and 2 questions for functions, a total of 11 questions for evaluation. 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: Baseline, 1 week, 4 week, 8 week, 12 week, 24 week, 52 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Severance Hospital
Seoul, South Korea
Change in the WOMAS(whole-organ magnetic resonance imaging score) at post-dose 52 weeks from the baseline
Total score is between 0 point (no symptoms) \~ 96 points (higher score representing worse symptoms).
Time frame: Baseline, 52 week
Change in T2 mapping at post-dose 52 weeks from the baseline
Changes on the knee structure through qualitative and quantitative evaluation of the collagen matrix of knee cartilage.
Time frame: Baseline, 52 week
Change in K&L grade, joint space width, mechanical axis, and anatomical axis at post-dose 52 weeks from the baseline
K \& L grade (0 to 4 Grade): which means that the higher the grade, the greater the joint damage and the stenosis of the joint. Joint space width(mm): Evaluation of disease progression in target knee as ascertained by change from baseline joint space width (JSW) determined using radiography. Mechanical axis(Angle): A line connecting the femoral head center point and the ankle joint center point. Anatomical axis(Angle): The middiaphyseal line of the femur and tibia
Time frame: Baseline, 52 week
Change amount of biomarkers at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks against the baseline; serum CTX-I, Serum HA, Serum MMP-3, Urine CTX-I, Urine CTX-II.
serum C-terminal cross-linking telopetides of collagen type I(CTX-I), serum hyaluronan, serum matrix metalloproteinase-3 (MMP-3), urine C-terminal cross-linking telopetides of collagen type II (CTX -II), urine C-terminal cross-linking telopetides of collagen type I(CTX-I). Serum CTX-I, Serum HA, Serum MMP-3, Urine CTX-I, Urine CTX-II are reported in pg/ml.
Time frame: baseline, 1 week, 4 week, 8 week, 12 week, 24 week, 52week
Percentage of patients who took the rescue drugs and dosage at post-dose 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks and 52 weeks
Subjects will receive Patient Diary, and use of the rescue drug should be recorded on the Patient Diary.
Time frame: 1 week, 4 week, 8 week, 12 week, 24 week, 52week