Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

NCT01056900 | Completed

• 1 other identifier: 05CON
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Articular Cartilage Defects of Knee

Keywords

articular cartilage defects; ACI; Autologous Chondrocyte Implantation; Knee joint; chondron

Outcome Measures

Primary Outcomes (1)

• Change of KSS(Knee Society Score)-A,B

  pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.

Secondary Outcomes (2)

• 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.

Study Arms (1)

Chondron 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

Procedure: Autologous Chondrocyte Implantation

Interventions

Autologous Chondrocyte Implantation 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.

Also known as: Chondron(671500010 [ A74600011 ])

Chondron Implantation

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this exploratory clinical trial Chondron (autologous chondrocytes) is transplanted in the cartilaginous defects and the effectiveness is observed through follow-up. Target subjects are about 5% of about 2,000 patients with Chondron implants.

You may qualify if:

• Adult males and females aged between 15 and 65
• Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually
• 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
• Patients whose surrounding cartilage is normal
• Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial

You may not qualify if:

• Patients hypersensitive to bovine protein
• Patients hypersensitive to antibiotics like gentamicin
• Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis
• Patients with arthritis associated with autoimmune diseases
• Patients who are pregnant, nursing a baby or likely to get pregnant
• Patients with other diseases including tumors except for cartilaginous defects of joints
• Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy
• 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)
• Patients with infections who are taking antibiotics and antimicrobial agents
• Patients who are treated with adrenal cortical hormones
• Patients whom the investigators find to be unfit for this clinical trial, such as mental patients

Sponsors & Collaborators

• Sewon Cellontech Co., Ltd.: lead

Study Sites (1)

Sewon Cellontech

Sungdong-ku, Seoul, 133-831, South Korea

Location

Study Officials

• Nam Yong Choi

  St. Paul Hospital of Catholic Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 26, 2010
• Study Start: December 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

KR (1)