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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539056 on ClinicalTrials.gov