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Completed

NCT Number: NCT01056900

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.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sewon Cellontech

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

Treatment and study plan

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.

Other names: Chondron(671500010 [ A74600011 ])

Primary outcomes

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

    Time frame: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.

Secondary outcomes

  1. Additional treatment related to autologous chondrocyte implantation

    Time frame: post -operation 4month, post-operation 12month, over post-operation 24month.

  2. Satisfaction of patients

    Time frame: post -operation 4month, post-operation 12month, over post-operation 24month.

Sponsors and collaborators

Lead sponsor

Cellontech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2010
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.