Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect
Condition: Articular Cartilage Defects of Ankle Joint
MeSH terms: Cartilage Diseases
Intervention: Chondron(autologous chondrocyte) Implantation
Intervention description: 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.
*30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 15 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: articular cartilage defects; ACI; ankle joint; chondron

Summary:

      An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage
      defect patients who are appropriate for the trial, and evaluating the validity and safety for
      12 months.
    

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