Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

Last updated: August 28, 2015
Sponsor: Sewon Cellontech Co., Ltd.
Overall Status: Trial Status Unknown

Phase

3

Condition

Osteoarthritis

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT02537067
04CON
  • Ages 15-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. 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:

    1. 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

This is an open label trial, involving a total of 28 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 6* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, x-ray, MRI tests and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 5 visits.

Connect with a study center

  • Myongji Hospital

    Goyang, Gyeonggi
    Korea, Republic of

    Site Not Available

  • Eulji General Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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