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Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

NCT02072070 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2017-11-17

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

Placebo

Placebo control(Normal Saline)

Sponsors & Collaborators

  • Kolon Life Science

    lead INDUSTRY

Principal Investigators

  • Jin Gu Kim, MD, PhD · Inje University

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

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

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

  • Yong In, MD, PhD · The Catholic University of Korea Seoul ST. Mary's Hospita

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

  • Seong Do Cho, MD, PhD · Ulsan University Hospital

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

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

  • Ju Hong Lee, MD, PhD · Chonbuk National University Hospital

  • Ui Seong Choi, MD, PhD · Chungbuk National University Hospital

  • Chung Hyeok Choi, MD, PhD · Hanyang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT02072070 on ClinicalTrials.gov