Articular Cartilage Defects of Knee
Conditions
Keywords
articular cartilage defects, ACI, Autologous Chondrocyte Implantation, Knee joint, chondron
Brief summary
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
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.
Interventions
PROCEDUREAutologous Chondrocyte Implantation
* 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.
Sponsors
Sewon Cellontech Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Adult males and females aged between 15 and 65 2. Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually 3. 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 4. Patients whose surrounding cartilage is normal 5. Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial *
Exclusion criteria
1. Patients hypersensitive to bovine protein 2. Patients hypersensitive to antibiotics like gentamicin 3. Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis 4. Patients with arthritis associated with autoimmune diseases 5. Patients who are pregnant, nursing a baby or likely to get pregnant 6. Patients with other diseases including tumors except for cartilaginous defects of joints 7. Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy 8. 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) 9. Patients with infections who are taking antibiotics and antimicrobial agents 10. Patients who are treated with adrenal cortical hormones 11. Patients whom the investigators find to be unfit for this clinical trial, such as mental patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of KSS(Knee Society Score)-A,B | pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month. |
Secondary
| Measure | 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. |
Countries
South Korea
Outcome results
None listed