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This study was aimed to evaluate effectiveness and safety of autologous chondrocyte suspension for treatment of knee articular cartilage defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Chondrocyte Injection | Experimental | Autologous chondrocytes were isolated and expanded in laboratory, then injected at 2x10^6 of cells per cm^2 of the cartilage defect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous chondrocytes | Other | autologous chondrocytes implantation (ACI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) | Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage reparation). | Up to 12 months. |
| Change in tissue integrity into and around the treated aera | MRI analysis | 3 months post-implantation |
| Absence of infection after implantation. | Absence of infection is assessed in blood sample by the quantification of three parameters: C-reactive Protein (CRP), neutrophil and lymphocyte rate. The non-infection is characterised by a CRP rate < 10 mg/L, neutrophil rate ranges from 40-75% and lymphocyte rate ranges from 25-40%. | 6 weeks post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported function and knee-related quality of life are assessed by using the Knee injury and Osteoarthritis Outcome Score (KOOS) | KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score). | Change from baseline to 12 months post-implantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin MARTIN, MD | Contact | 021 314 76 79 | 41 | robin.martin@chuv.ch |
| Virginie PHILIPPE, Ph-D | Contact | 021 314 90 18 | 41 | virginie.philippe@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Robin MARTIN, MD | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois - CHUV | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002357 | Cartilage Diseases |
| D003240 | Connective Tissue Diseases |
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| Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC) | A score will be calculated, and it ranges from 0 (worst score) to 100 (best score). | Change from baseline to 12 months post-implantation |
| Self-reported functional health and weel-being as assessed by SF12 Survey | SF12 survey includes 2 subscales: mental component summary (MCS) and physical component summery (PCS). A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score). | Change from baseline to 12 months post-implantation |
| The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system. | MOCART scoring system is based on MRI analysis. A score in points will be calculated, and it ranges from 0 points (no repair) to 100 points (excellent cartilage defect repair) | Change from baseline to12 months post-implantation |
| D017437 |
| Skin and Connective Tissue Diseases |