Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

NCT ID: NCT01050816

Last Updated: 2010-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-02-28

Brief 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.

Detailed Description

This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.

Conditions

Articular Cartilage Defects of Ankle Joint

Study Design

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

Study Groups

Chondron implantation

ankle cartilage defect patients who had CHONDRON transplantation

Group Type: EXPERIMENTAL

Chondron(autologous chondrocyte) Implantation

Intervention Type: PROCEDURE

• 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.

Interventions

Chondron(autologous chondrocyte) Implantation

• 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.

Intervention Type: PROCEDURE

Other Intervention Names

Chondron

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sewon Cellontech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Eulji General Hospital

Principal Investigators

Gyeung Tea Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Eulji General Hospital

Locations

Sewon Cellontech

Seoul, Sungdong-ku, South Korea

Countries

South Korea

Other Identifiers

02CON

Identifier Type: -

Identifier Source: org_study_id