Observation of the Result After Chondron (Autologous Chondrocytes) Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Articular Cartilage Defects of Knee

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Autologous Chondrocyte Implantation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Chondron(671500010 [ A74600011 ])

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No