Knee Osteoarthritis
Conditions
Keywords
human umbilical cord blood derived mesenchymal stem cells, hUC-MSCs, Knee Osteoarthritis
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
BIOLOGICALSMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
DRUGHigh Hyal Plus
A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml)
Sponsors
Medipost Co Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Phase 2's long term follow-up Study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase II clinical trial. 2. Subject who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Exclusion criteria
1. Subject who were not enrolled in phase II clinical trial of SMUP-IA-01 for assessing safety and explore efficacy. 2. Other subjects, excluding those listed above, who were deemed unsuitable by the PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of total score in WOMAC (Western Ontario and McMaster University) | Time Frame: Month 12, 24, 36, 48 and 60 after treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of score in 100 mm VAS (Visual Analogue Scale) | Time Frame: Month 12, 24, 36, 48 and 60 after treatment | The score ranges from 0 or no pain to 100 very severe pain |
| Change of score in IKDC(International Knee Documentation Committee) | Time Frame: Month 12, 24, 36, 48 and 60 after treatment | 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. |
| Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score) | Time Frame: Month 12 and 24 after treatment | 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 |
| Change of score in WOMAC three subscales (Pain, stiffness, physical function) aginst MP-SMUP-IA-01-P02's baseline. | Time Frame: Month 12, 24, 36, 48 and 60 after treatment | 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). |
| Change in joint space width | Time Frame: Month 12, 24 and 60 after treatment | Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography |
| Change in mechanical axis, anatomical axis | Time Frame: Month 12, 24 and 60 after treatment | 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 |
| Change in K&L(Kellgren-Lawrence) grade | Time Frame: Month 12, 24 and 60 after treatment | 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 |
Countries
South Korea
Outcome results
None listed