Clinical Trials Logo
  1. Home
  2. Degenerative Arthritis
  3. NCT01671072

Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

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

Clinical Trial 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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01671072
Study type Interventional
Source Kolon Life Science
Contact
Status Completed
Phase Phase 2
Start date July 2011
Completion date January 2013
View Details
See also
  Status Clinical Trial Phase
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A
Withdrawn NCT01308515 - Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study N/A
Terminated NCT03247023 - Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
Terminated NCT05357664 - PINNACLE® DM RSA Study N/A
Completed NCT01825811 - Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis Phase 2
Terminated NCT01366989 - INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation N/A
Not yet recruiting NCT02286973 - Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty Phase 1
Completed NCT02072070 - Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis Phase 3
Completed NCT01684371 - The Effects of Elmore Oil on Patients With Osteoarthritis N/A
Recruiting NCT00891501 - The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects Phase 2/Phase 3
Completed NCT03000712 - Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients. N/A
Withdrawn NCT04057885 - To Determine the Gait and Functional Improvement in Total Knee Arthroplasty N/A
Completed NCT04815070 - Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty
Active, not recruiting NCT02038140 - Zimmer Trabecular Metal Total Ankle PMCF N/A
Recruiting NCT02469662 - Clinical Outcomes Study of the Nexel Total Elbow N/A
Terminated NCT00588887 - Total Knee Replacement With Duracon® and Vanguard™ Prostheses N/A
Completed NCT03990805 - A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis Phase 3
Completed NCT02658344 - Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis Phase 2
Not yet recruiting NCT04821102 - Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM Administration N/A
Terminated NCT02405234 - Ascension PyroCarbon Radial Head Study N/A