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| Name | Class |
|---|---|
| Kyung Hee University Hospital | OTHER |
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The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CartiLife (low-dose group) | Experimental | Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed. |
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| CartiLife (high-dose group) | Experimental | Total defect volume in High-dose group is 2 ~ 4 ㎤. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CartiLife | Drug | Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection with a fibrin adhesive through minimal arthrotomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse events | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IKDC (International Knee Documentation Committee) | Changes in IKDC scores during each visit The IKDC Score is a subjective questionnaire filled out by the patient ranges from 0-100, where a score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms | Baseline to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoung Ho Yoon, MD, PhD | Kyunghee University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32125878 | Derived | Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3. |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| X-ray |
Changes in structure during each visit |
| Baseline 48 weeks |