Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

Study Overview
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Brief Summary
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This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.

Detailed Description
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Many treatment cases proved that autologous chondrocyte transplantation is a useful treatment method for patients with damaged articular cartilage. This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron(autologous chondrocyte) transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.

Official Title
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An Investigator-sponsored Trial for Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

Conditions
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Articular Cartilage Defects of Knee

Intervention / Treatment
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* Procedure: Autologous Chondrocyte Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and females aged between 15 and 65 Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually Patients with misalignment between tibia and talus of the ankle joint, lateral ankle instability, and a bony defect in the cartilaginous defect or who had a correction simultaneously or in advance Patients whose surrounding cartilage is normal Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial Exclusion Criteria: Patients hypersensitive to bovine protein Patients hypersensitive to antibiotics like gentamicin Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis Patients with arthritis associated with autoimmune diseases Patients who are pregnant, nursing a baby or likely to get pregnant Patients with other diseases including tumors except for cartilaginous defects of joints Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy Diabetics (however, patients who were normal in the blood glucose test and have no complication due to diabetes will be excluded if the doctor says Chondron can be administered to them) Patients with infections who are taking antibiotics and antimicrobial agents Patients who are treated with adrenal cortical hormones Patients whom the investigators find to be unfit for this clinical trial, such as mental patients

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chondron Implantation<br>This clinical trial was a follow-up study involving 127 patients from 10 hospitals, for whom autologous chondrocyte transplantation was already performed. All the subjects were investigated as a single group | Procedure: Autologous Chondrocyte Implantation<br>* Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial) Directions and dosage: Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected.<br>* Other names: Chondron(671500010 [ A74600011 ]);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of KSS(Knee Society Score)-A,B |  | pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional treatment related to autologous chondrocyte implantation |  | post -operation 4month, post-operation 12month, over post-operation 24month. | 
| Satisfaction of patients |  | post -operation 4month, post-operation 12month, over post-operation 24month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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articular cartilage defects, ACI, Autologous Chondrocyte Implantation, Knee joint, chondron