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Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study
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| Measure | Description | Time Frame |
|---|---|---|
| Number of AESI | 5 years follow-up after treatment | |
| Number of SS | 5 years follow-up after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) | The higher the score, the worse the condition of the disease is. | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
| Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) |
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Inclusion Criteria:
exclusion criteria
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Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaeeun JEON | Contact | 02-2036-7614 | cejeon@kangstem.com | |
| Hyeseung JEON | Contact | 02-888-1592 | hsjeon@kangstem.com |
| Name | Affiliation | Role |
|---|---|---|
| Kyoung-Ho Yoon, professor (CI) | Kyung Hee University Hospital | Principal Investigator |
| Sang Hak Lee, professor | Gangdong Kyunghee University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper. |
| 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
| Changes in 100-mm VAS | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
| Changes in International Knee Documentation Committee Scoring System (IKDC) | A higher score indicates better function and less symptomatic | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
| Evaluation of International K&L grade(X-ray) | Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI) | A higher score indicates better function and less symptomatic | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
| Whole-Organ Magnetic Resonance Imaging Score (WORMS) score | The higher the score means normal state. | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
| D012216 |
| Rheumatic Diseases |