NCT01050816

Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Articular Cartilage Defects of Ankle Joint

Interventions

Type	Name	Description
PROCEDURE	Chondron(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. \*30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation.

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2010-01-15
• Last updated: 2010-05-11
• Results posted: 2010-05-07

Locations

1 site across 1 country: South Korea