Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

Sewon Cellontech

Status and phase: Completed; Phase 3

Conditions: Articular Cartilage Defects of Ankle Joint

Treatments: Procedure: Chondron(autologous chondrocyte) Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01050816

02CON

Details and patient eligibility

About

An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.

Full description

This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.

Enrollment: 30 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. adult men and women over 15 and less than 65 years of age
2. applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
3. patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance.
4. patients which surrounding cartilage are normal
5. patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form

Exclusion criteria

1. patients hypersensitive to bovine protein
2. patients hypersensitive to gentamicin antibiotics
3. patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
4. patients with arthritis related to autoimmune disease
5. pregnant, breast-feeding patients or those who have a possibility of pregnancy
6. patients with accompanying diseases other than articular cartilage defects, including tumors
7. patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
8. patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)
9. patients who are administering antibiotics and antimicrobial agents due to infection
10. patients who receive steroid hormone therapy
11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Chondron implantation

Experimental group

Description:

ankle cartilage defect patients who had CHONDRON transplantation

Treatment:

Procedure: Chondron(autologous chondrocyte) Implantation