Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

Sewon Cellontech

Status: Completed

Conditions: Articular Cartilage Defects of Knee

Treatments: Procedure: Autologous Chondrocyte Implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT01056900

05CON

Details and patient eligibility

About

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

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

127 participants in 1 patient group

Chondron Implantation

Description:

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

Treatment:

Procedure: Autologous Chondrocyte Implantation