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Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis

NCT02341391 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-07-05

No results posted yet for this study

Summary

The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination findings, and the laboratory test results after the intra-articular injection of TissueGene-C.

And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion, functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the injection site.

Conditions

  • Degenerative Arthritis

Interventions

BIOLOGICAL

TissueGene-C(Low dose)

3.0 x 10\^6 cells

BIOLOGICAL

TissueGene-C(Medium dose)

1.0 x 10\^7 cells

BIOLOGICAL

TissueGene-C(High dose)

3.0 x 10\^7 cells

Sponsors & Collaborators

  • Kolon Life Science

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-08-31
Completion
2008-09-30

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 NCT02341391 on ClinicalTrials.gov