Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

January 24, 2010 updated by: Sewon Cellontech Co., Ltd.

An Investigator-sponsored Trial for Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Sungdong-ku, Seoul, Korea, Republic of, 133-831
        • Sewon Cellontech

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
  • 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.

Other Names:
  • Chondron(671500010 [ A74600011 ])

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of KSS(Knee Society Score)-A,B
Time Frame: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.
pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional treatment related to autologous chondrocyte implantation
Time Frame: post -operation 4month, post-operation 12month, over post-operation 24month.
post -operation 4month, post-operation 12month, over post-operation 24month.
Satisfaction of patients
Time Frame: post -operation 4month, post-operation 12month, over post-operation 24month.
post -operation 4month, post-operation 12month, over post-operation 24month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sewon Cellontech Co., Ltd.

Investigators

  • Principal Investigator: Nam Yong Choi, St. Paul Hospital of Catholic Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 24, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 24, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05CON

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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