Last updated: August 28, 2015
Sponsor: Sewon Cellontech Co., Ltd.
Overall Status: Trial Status Unknown
Phase
3
Condition
Osteoarthritis
Musculoskeletal Diseases
Treatment
N/AClinical Study ID
NCT02537067
04CON
Ages 15-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult men and women over 15 and less than 65 years of age 2. Applicable to patientswho have a partial cartilage defect in their ankle based on an MRI (defect size: for asingle lesion, less than 15 cm2; and for multiple lesions, less than 20 cm2) 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 inadvance 4. Patients which surrounding cartilage are normal 5.Patients with a Grade IIIor IV cartilage defect size on the ICRS (International Cartilage Repair Society) 6.Patients who agreed to clinical trial participation voluntarily or by the will of theperson in parental authority, and signed the written consent form
Exclusion
Exclusion Criteria:
- Patients hypersensitive to bovine protein 2. Patients hypersensitive to gentamicinantibiotics 3. Patients with inflammatory arthritis such as rheumatoid arthritis, goutarthritis 4. Patients with arthritis related to autoimmune disease 5. Pregnant,breast-feeding patients or those who have a possibility of pregnancy 6. Patients withaccompanying diseases other than articular cartilage defects, including tumors 7.Patients who have a history of receiving radiotherapy, chemotherapy in the last 2years 8. Patients with diabetes (however, patients whose blood sugar test results arenormal and do not have any complication of diabetes, when a written opinion thatCHONDRON administration is possible is appended by a doctor are excluded) 9. Patientswho are administering antibiotics and antimicrobial agents due to infection 10.Patients who receive steroid hormone therapy 11. Patients with psychiatric disorderand those who are considered to be inappropriate for this trial by the judgment of theclinical trial manager
Study Design
Total Participants: 28
Study Start date:
January 01, 2010
Estimated Completion Date:
December 31, 2015
Study Description
Connect with a study center
Myongji Hospital
Goyang, Gyeonggi
Korea, Republic ofSite Not Available
Eulji General Hospital
Seoul,
Korea, Republic ofSite Not Available
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