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The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)
Sponsor: Sewon Cellontech Co., Ltd.
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
Conditions
Interventions
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