Overview

This trial is active, not recruiting.

Conditions defect of articular cartilage, degenerative joint disease of ankle and/or foot, ankle (ligaments); instability, familial
Treatment chondron
Phase phase 3
Sponsor Sewon Cellontech Co., Ltd.
Start date January 2010
End date May 2015
Trial size 28 participants
Trial identifier NCT02537067, 04CON

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant.
chondron Autologous cultured Chondrocyte
Harvesting of ankle or knee cartilage The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.

Primary Outcomes

Measure
Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
time frame: 12 months after the surgery

Secondary Outcomes

Measure
Score change of AOFAS(American orthopedic foot & ankle society) Score
time frame: baseline and six, 12 and 18 months after the surgery
Hannover Score
time frame: baseline and six, 12 and 18 months after the surgery
Score change of Evaluation by physician in charge
time frame: six, 12 and 18 months after the surgery
Score change of 100mmVAS(visual analogue scale)
time frame: baseline and six, 12 and 18 months after the surgery
Comparing MRI results
time frame: baseline and 18 months after the surgery

Eligibility Criteria

Male or female participants from 15 years up to 65 years old.

Inclusion Criteria: - 1. Adult men and women over 15 and less than 65 years of age 2. Applicable to patients who have a partial cartilage defect in their ankle based on an MRI (defect size: for a single 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 in advance 4. Patients which surrounding cartilage are normal 5.Patients with a Grade III or 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 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

Additional Information

Official title A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle for 18 Months
Principal investigator Jin Su Kim, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Sewon Cellontech Co., Ltd..