Trials / Completed
CompletedNCT02072070
Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
A Placebo Controlled, Double-blind, Randomized, Parallel-group, Multi-center Phase III Study to Determine the Efficacy and Safety of TissueGene-C in Patients With Degenerative Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 163 (actual)
- Sponsor
- Kolon Life Science · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period. During the Phase 3 clinical trial , we will compare TissueGene-C to placebo in 26, 52 weeks trial with 156 outpatients who have osteoarthritis. The outpatients are randomized to TissueGene-C or placebo in 1:1 ratio, and they will be monitored and recorded in terms of alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TissueGene-C | TissueGene-C at 1.8 x 10\^7 cells |
| DRUG | Placebo | Placebo control(Normal Saline) |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-02-26
- Last updated
- 2017-11-17
Locations
12 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02072070. Inclusion in this directory is not an endorsement.