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This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K&L Grade III/IV.
Study Design: open-label, single-center, dose-escalation study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANT-301 | Experimental | Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANT-301 | Biological | Administration on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | Number of Adverse events and Laboratory Abnormalities | Week 2, 4, 8, 12, 24 and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain improvement according to VAS scale measurements | The VAS scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain. | Baseine, Week 4, 8, 12, 24 and Month 12 |
| IKDC score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University | Seoul | Seoul | 03080 | South Korea |
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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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IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
| Baseline, Week 4, 8, 12, 24 and 12 months |
| WOMAC questionnaire score | Difference in WOMAC questionnaire scores between baseline and each visit | Baseline, Week 4, 8, 12, 24 and 12 months |
| D012216 |
| Rheumatic Diseases |