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Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

NCT01671072 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-01-22

No results posted yet for this study

Summary

The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis

Conditions

  • Degenerative Arthritis

Interventions

BIOLOGICAL

TissueGene-C

TissueGene-C at 1.8 x 10\^7 cells

DRUG

Normal Saline

Sodium chloride 0.9%, 3.5ml

Sponsors & Collaborators

  • Kolon Life Science

    lead INDUSTRY

Principal Investigators

  • Chul Won Ha, MD, PhD · Samsung Medical Center

  • Seong Il Bin, MD, PhD · Asan Medical Center

  • Myung Chul Lee, MD, PhD · Seoul National Univ. Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • South Korea

Study Locations

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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 NCT01671072 on ClinicalTrials.gov