Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing TGF-b1, is effective and safe in patients with degenerative arthritis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Placebo Controlled, Single-blind, Randomized, Multi-center Phase IIb Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis|
- Changes in IKDC Subjective Score. [ Time Frame: Week 0, 4, 12, 24 and 48 ] [ Designated as safety issue: No ]Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
- Changes in WOMAC scores. [ Time Frame: Week 0, 4, 12, 24 and 48 ] [ Designated as safety issue: No ]Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
- Changes in KOOS scores. [ Time Frame: Week 0, 4, 12, 24 and 48 ] [ Designated as safety issue: No ]Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Changes in 100 mm-VAS. [ Time Frame: Week 0, 4, 12, 24 and 48 ] [ Designated as safety issue: No ]Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
- MRI scan [ Time Frame: Week 0, 24 and 48 ] [ Designated as safety issue: Yes ]Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 following dosing by an independent radiographic reviewer.
|Study Start Date:||July 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Single intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells
Tissuege-C at 1.8 x 10^7 cells
Placebo Comparator: Placebo
Single intra-articular injection to the damaged knee joint at the same volume
Placebo control(Normal Saline)
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.
|Korea, Republic of|
|Samsung Medical Center|
|Gangnam-gu, Seoul, Korea, Republic of, 135-710|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Seoul National Univ. Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Chul Won Ha, MD, PhD||Samsung Medical Center|
|Principal Investigator:||Seong Il Bin, MD, PhD||Asan Medical Center|
|Principal Investigator:||Myung Chul Lee, MD, PhD||Seoul National Univ. Hospital|