Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

Launched by SEWON CELLONTECH CO., LTD. · Jan 14, 2010

Keywords

ClinConnect Summary

This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER s...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. adult men and women over 15 and less than 65 years of age
• • 2. applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
• • 3. patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance.
• • 4. patients which surrounding cartilage are normal
• • 5. patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form
• Exclusion Criteria:
• • 1. patients hypersensitive to bovine protein
• • 2. patients hypersensitive to gentamicin antibiotics
• • 3. patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
• • 4. patients with arthritis related to autoimmune disease
• • 5. pregnant, breast-feeding patients or those who have a possibility of pregnancy
• • 6. patients with accompanying diseases other than articular cartilage defects, including tumors
• • 7. patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
• • 8. 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)
• • 9. patients who are administering antibiotics and antimicrobial agents due to infection
• • 10. patients who receive steroid hormone therapy
• • 11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager