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The purpose of this study is to evaluate the safety and efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) on currently standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus.
same as above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cartistem | Experimental | For control group patients currently standard treatment of arthroscopic curettage and microfracture is performed, and for study group patients allogenic umbilical cord blood-derived mesenchymal stem cell product(Cartistem®) is added on the lesion after above mentioned procedure. |
|
| standard treatment | Active Comparator | standard treatment of arthroscopic curettage and microfracture for osteochondral lesion of talus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cartistem | Biological | Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by American Orthopaedic Foot and Ankle Society(AOFAS) HINDFOOT/ANKLE SCALE | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by 100-mm VAS(Visual Analogue Scale) | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the efficacy of adding allogenic umbilical cord blood-derived stem cell product(Cartistem®) by ICRS arthroscopic scale for repair of articular cartilage | Baseline, Week 4, Week 8, Week 12, Week 24, Week 48 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Gangnam-Gu | Seoul | 135-710 | South Korea |
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