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NCT02539056
NA

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

Sponsor: Sewon Cellontech Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2012-10-15

Completion Date

2016-03-18

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

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.

Locations (2)

Inha Univerisity Hospital

Incheon, Incheon, South Korea

Ewha Womans University Mokdong Hospital

Seoul, Seoul, South Korea