The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)
NCT02539056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-04-08
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.
Conditions
- Osteoarthritis
- Traumatic Arthritis
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.
Sponsors & Collaborators
-
Sewon Cellontech Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Myung Ku Kim, MD · Inha University Hospital
-
Jae Doo Yoo, MD · Ewha Womans University Mokdong Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-10-15
- Primary Completion
- 2016-03-18
- Completion
- 2016-03-18
Countries
- South Korea
Study Locations
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