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Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis

NCT01825811 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-01-22

No results posted yet for this study

Summary

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

Conditions

  • Degenerative Arthritis

Interventions

BIOLOGICAL

TissueGene-C (Low dose)

TissueGene-C at 1.0 x 10\^6 cells mixed with fibrin-glue

BIOLOGICAL

TissueGene-C (High dose)

TissueGene-C at 3.0 x 10\^6 cells mixed with fibrin-glue

Sponsors & Collaborators

  • Kolon Life Science

    lead INDUSTRY

Principal Investigators

  • Myung Chul Lee, MD, PhD · Seoul National University Hospital

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

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

  • Myung Gu Kim, MD, PhD · Inha University Hospital

  • Jae Doo Yoo, MD, PhD · Ewha Womans University Mokdong Hospital

  • Hee Su Kyung, MD, PhD · Kyungpook National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-04-30
Completion
2014-06-30

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 NCT01825811 on ClinicalTrials.gov