At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 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 II Study to Determine the Efficacy and Safety of Allogeneic Human Chondrocytes Expressing TGF-β1 (TissueGene-C) in Patients With Grade 3 Chronic Degenerative Joint Disease of the Knee
In Brief
A Phase 2 clinical trial evaluating TissueGene-C and Normal Saline for Osteoarthritis, Knee. Completed, enrolled 102 participants across 5 sites.
Detailed Summary
The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartMay 2011
Primary CompletionOct 2013
Study CompletionOct 2014
TodayJul 2026
First PostedOct 15, 2010
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.7 years ago
Interventions
TissueGene-Cbiological
Single intraarticular injection at 3 x 10e7 cells
Normal Salinedrug
Single intraarticular injection of normal saline as a placebo control