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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 II trial (NCT05182034) will be followed-up until 60 months.
The subjects will be followed up at 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMUP-IA-01(low-dose) | Experimental | A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) |
|
| SMUP-IA-01(mid-dose) | Experimental | A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) |
|
| High Hyal Plus Inj. | Active Comparator | A single knee administration of High Hyal Plus Inj.(1% Sodium Hyaluronate 20mg/2ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMUP-IA-01(low-dose) | Biological | A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of score in WOMAC three subscales (Pain, stiffness, physical function) aginst MP-SMUP-IA-01-P02's 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: Month 12, 24, 36, 48 and 60 after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Nation University Bundang Hospital | Gyeonggi-do | South Korea | ||||
| Gangnam Severance Hospital |
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Phase 2's long term follow-up Study
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| SMUP-IA-01(mid-dose) | Biological | A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL) |
|
|
| High Hyal Plus | Drug | A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml) |
|
| 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 | Time Frame: Month 12, 24 and 60 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, 24 and 60 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, 24 and 60 after treatment |
| Seoul |
| South Korea |
| Korea University Anam Hospita | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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