NCT02537067

Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle for 18 Months

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months

Detailed description

This is an open label trial, involving a total of 28 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 6\* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, x-ray, MRI tests and arthroscopy will be performed. \*If tissue samples can be collected at screening visit, there will be only 5 visits.

Conditions

• Defect of Articular Cartilage
• Degenerative Joint Disease of Ankle and/or Foot
• Ankle (Ligaments); Instability, Familial

Interventions

Type	Name	Description
DRUG	CHONDRON	1. Harvesting of ankle or knee cartilage 2. The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-05-01
• Completion: 2015-11-01
• First posted: 2015-09-01
• Last updated: 2026-04-08

Locations

2 sites across 1 country: South Korea