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The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondrocyte) by Arthroscopy
Sponsor: Sewon Cellontech Co., Ltd.
Summary
A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in patients with knee cartilage defects.
Official title: A Post-marketing Surveillance to Evaluate the Efficacy and Safety of CHONDRON (Autologous Cultured Chondrocyte) Through Arthroscopy in Patients With Knee Cartilage Defects
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2012-10-23
Completion Date
2016-01-15
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 (1)
Yonsei University Severance Hospital
Seoul, Seoul, South Korea