Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
Study Details
Study Description
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 I trial (NCT04037345 ) will be followed-up until 60 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SMUP-IA-01(low-dose) 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) |
Biological: SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL)
Other Names:
|
| Experimental: SMUP-IA-01(mid-dose) 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) |
Biological: SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL)
Other Names:
|
| Experimental: SMUP-IA-01(high-dose) A single knee administration of SMUP-IA-01 (high-dose, 2.0 x 10^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01) |
Biological: SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10^7 cells/2mL)
|
Outcome Measures
Primary Outcome Measures
- Change of total score in WOMAC (Western Ontario and McMaster University) [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 Outcome Measures
- Change of score in WOMAC three subscales (Pain, stiffness, physical function) [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 of score in 100 mm VAS (Visual Analogue Scale) [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) [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) [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 in K&L(Kellgren-Lawrence) grade [Month 12 and 24 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
- Change in joint space width [Month 12 and 24 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 [Month 12 and 24 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
- Rate of surgery to treat application site after treatment of SMUP-IA-01 [Month 6, 12, 24, 36, 48 and 60 after treatment]
Rate of surgery to treat application site after treatment of SMUP-IA-01
- Changes in biomarker [Month 12 after treatment]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial.
-
Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
-
Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Exclusion Criteria:
-
Subjects who were not enrolled in phase 1 clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
-
Other subjects, excluding those listed above, who were deemed unsuitable by the PI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul national University Hospital | Seoul | Jongno-gu | Korea, Republic of | 03080 |
Sponsors and Collaborators
- Medipost Co Ltd.
Investigators
- Principal Investigator: Myungchul LEE, MD, PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MP-SMUP-IA-P01-F/U