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

NCT ID: NCT02537067

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-12-31

Brief 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

Detailed 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.

Conditions

Defect of Articular Cartilage; Degenerative Joint Disease of Ankle and/or Foot; Ankle (Ligaments); Instability, Familial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous cultured Chondrocyte

Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant.

Group Type: EXPERIMENTAL

CHONDRON

Intervention Type: DRUG

1. Harvesting of ankle or knee cartilage

2. The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.

Interventions

CHONDRON

1. Harvesting of ankle or knee cartilage

2. The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.

Intervention Type: DRUG

Other Intervention Names

Autologous cultured Chondrocyte

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sewon Cellontech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Su Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Eulji General Hospital

Ki Hyuck Sung, MD

Role: PRINCIPAL_INVESTIGATOR

Myongji Hospital

Locations

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Eulji General Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

04CON

Identifier Type: -

Identifier Source: org_study_id