Clinical trial NCT01056900: Observation of the Result After Chondron (Autologous Chondrocytes) Treatment
Official title: An Investigator-sponsored Trial for Observation of the Result After Chondron (Autologous Chondrocytes) Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Articular Cartilage Defects of Knee
Keywords: articular cartilage defects
ACI
Autologous Chondrocyte Implantation
Knee joint
chondron
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 127
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Change of KSS(Knee Society Score)-A,B
timeFrame: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.
Secondary outcomes:
measure: Additional treatment related to autologous chondrocyte implantation
timeFrame: post -operation 4month, post-operation 12month, over post-operation 24month.
measure: Satisfaction of patients
timeFrame: post -operation 4month, post-operation 12month, over post-operation 24month.
Other outcomes:
Locations:
city: Sungdong-ku
country: Korea, Republic of
facility: Sewon Cellontech
state: Seoul
Study officials:
affiliation: St. Paul Hospital of Catholic Medical College
name: Nam Yong Choi
role: PRINCIPAL_INVESTIGATOR
References: