MedTrace Logo

Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

NCT01050816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-05-11

Study results available
· View outcomes & findings →

Summary

An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.

Conditions

  • Articular Cartilage Defects of Ankle Joint

Interventions

PROCEDURE

Chondron(autologous chondrocyte) Implantation

* Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial) * Directions and dosage: Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected. \*30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation.

Sponsors & Collaborators

  • Sewon Cellontech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Gyeung Tea Lee, MD · Eulji General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT01050816 on ClinicalTrials.gov