Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

Completed

• Conditions: Articular Cartilage Defects of Knee
• Interventions: Procedure: Autologous Chondrocyte Implantation

• Registration Number: NCT01056900
• Lead Sponsor: Sewon Cellontech Co., Ltd.

Brief Summary

This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.

Detailed Description

Many treatment cases proved that autologous chondrocyte transplantation is a useful treatment method for patients with damaged articular cartilage.

This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron(autologous chondrocyte) transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-08
• Study Completion: 2009-11
• Status Verified: 2010-01
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-24
• Last Update Submitted: 2010-01-24
• Study First Posted: 2010-01-26
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

1. Adult males and females aged between 15 and 65
2. Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually
3. Patients with misalignment between tibia and talus of the ankle joint, lateral ankle instability, and a bony defect in the cartilaginous defect or who had a correction simultaneously or in advance
4. Patients whose surrounding cartilage is normal
5. Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial

Exclusion Criteria

1. Patients hypersensitive to bovine protein
2. Patients hypersensitive to antibiotics like gentamicin
3. Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis
4. Patients with arthritis associated with autoimmune diseases
5. Patients who are pregnant, nursing a baby or likely to get pregnant
6. Patients with other diseases including tumors except for cartilaginous defects of joints
7. Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy
8. Diabetics (however, patients who were normal in the blood glucose test and have no complication due to diabetes will be excluded if the doctor says Chondron can be administered to them)
9. Patients with infections who are taking antibiotics and antimicrobial agents
10. Patients who are treated with adrenal cortical hormones
11. Patients whom the investigators find to be unfit for this clinical trial, such as mental patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chondron Implantation	Autologous Chondrocyte Implantation	This clinical trial was a follow-up study involving 127 patients from 10 hospitals, for whom autologous chondrocyte transplantation was already performed. All the subjects were investigated as a single group

Primary Outcome Measures

Name	Time	Method
Change of KSS(Knee Society Score)-A,B	pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.

Secondary Outcome Measures

Name	Time	Method
Additional treatment related to autologous chondrocyte implantation	post -operation 4month, post-operation 12month, over post-operation 24month.
Satisfaction of patients	post -operation 4month, post-operation 12month, over post-operation 24month.

Trial Locations

Locations (1)

Sewon Cellontech; 🇰🇷 Sungdong-ku, Seoul, Korea, Republic of