Degenerative Arthritis Clinical Trial
Official title:
A Placebo Controlled, Single-blind, Randomized, Multi-center Phase 2B Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis
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
TissueGene-C is a biological new drug which consists of normal chondrocytes and transduced
chondrocytes that express growth factors to regenerate the damaged cartilage tissues.
In the clinical trial Phase 2b, the investigators compared TissueGene-C to placebo during 6
- months trial with 54 outpatients who have had degenerative arthritis. The outpatients are
assigned to TissueGene-C or placebo in 1:1 ratio, and will be monitored and recorded for
improving clinical symptoms, sports activities, and function of the knee, and for the
presence of adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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