The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cul… (NCT02539056) | Clinical Trial Compass
CompletedNot Applicable
The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)
South Korea22 participantsStarted 2012-10-15
Plain-language summary
A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.
Who can participate
Age range15 Years
SexALL
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Inclusion criteria
✓. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) \* For a single lesion, less than 15 cm2 cartilage defects; and for multiple lesions, less than 20 cm2
✓. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
✓. Patients which surrounding cartilage are normal
✓. Patients who were 15 years old or older
✓. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form
Exclusion criteria
✕. Patients hypersensitive to bovine protein
✕. Patients hypersensitive to gentamicin antibiotics
✕. Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
✕. Patients with arthritis related to autoimmune disease
✕. Pregnant, breast-feeding patients or those who have a possibility of pregnancy
✕. Patients with accompanying diseases other than articular cartilage defects, including tumors (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
. Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
✕. Patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)