At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
TissueGene-C +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients With Degenerative Joint Disease Prior to Total Knee Arthroplasty
In Brief
A Phase 1 clinical trial evaluating TissueGene-C and Placebo for Osteoarthritis, Knee. Completed, enrolled 12 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2008
Primary CompletionMay 2009
Study CompletionMay 2010
TodayJul 2026
First PostedJan 23, 2008
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.4 years ago
Interventions
TissueGene-Cbiological
TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
Placebobiological
Placebo control (DMEM)