NCT02539056

The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)

This Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte) in Patients With Cartilage Defects in Their Knees.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.

Detailed description

This is an open trial, involving a total of 24 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 8\* 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, blood samples, x-ray, MRI tests, observation with the naked eyes and arthroscopy will be performed. \*If tissue samples can be collected at screening visit, there will be only 7 visits.

Conditions

• Osteoarthritis
• Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Chondron Implantation	In one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) 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: 2012-10-15
• Primary completion: 2016-03-18
• Completion: 2016-03-18
• First posted: 2015-09-02
• Last updated: 2026-04-08

Locations

2 sites across 1 country: South Korea