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Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee

NCT00599248 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-07-07

Study results available
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Summary

The study is being conducted to investigate the safety and activity of TissueGene-C injected into the knee joint of patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

TissueGene-C

TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection

BIOLOGICAL

Placebo

Placebo control (DMEM)

Sponsors & Collaborators

  • Kolon TissueGene, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Mont, MD · Sinai Hospital of Baltimore

  • David Romness, MD · Commonwealth Orthopedics, Virginia Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-05-31
Completion
2010-05-31

Countries

  • United States

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 NCT00599248 on ClinicalTrials.gov