Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

This study has been completed.
Sponsor:
Information provided by:
Sewon Cellontech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01056900
First received: January 21, 2010
Last updated: January 24, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention
Articular Cartilage Defects of Knee
Procedure: Autologous Chondrocyte Implantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Investigator-sponsored Trial for Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

Further study details as provided by Sewon Cellontech Co., Ltd.:

Primary Outcome Measures:
  • Change of KSS(Knee Society Score)-A,B [ Time Frame: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional treatment related to autologous chondrocyte implantation [ Time Frame: post -operation 4month, post-operation 12month, over post-operation 24month. ] [ Designated as safety issue: No ]
  • Satisfaction of patients [ Time Frame: post -operation 4month, post-operation 12month, over post-operation 24month. ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Chondron(671500010 [ A74600011 ])

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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056900

Locations
Korea, Republic of
Sewon Cellontech
Sungdong-ku, Seoul, Korea, Republic of, 133-831
Sponsors and Collaborators
Sewon Cellontech Co., Ltd.
Investigators
Principal Investigator: Nam Yong Choi St. Paul Hospital of Catholic Medical College
  More Information

No publications provided

Responsible Party: Nam Yong, Choi, St.Paul Hospital of Catholic University
ClinicalTrials.gov Identifier: NCT01056900     History of Changes
Other Study ID Numbers: 05CON
Study First Received: January 21, 2010
Last Updated: January 24, 2010
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Sewon Cellontech Co., Ltd.:
articular cartilage defects
ACI
Autologous Chondrocyte Implantation
Knee joint
chondron

ClinicalTrials.gov processed this record on July 22, 2014