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Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee
Sponsor: Kolon TissueGene, Inc.
Summary
A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the efficacy and safety of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
531
Start Date
2021-12-09
Completion Date
2026-03-06
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
TG-C
2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1
Placebo Control
2 mL normal saline intraarticular injection
Locations (27)
Nebojsa Skrepnik
Tucson, Arizona, United States
Steve Sitar
Anaheim, California, United States
Stuart Silverman
Beverly Hills, California, United States
Samy Metyas
Covina, California, United States
Bassil Aish
Huntington Beach, California, United States
Peter Hanson
La Mesa, California, United States
John Beckes
San Diego, California, United States
Miguel Trevino
Clearwater, Florida, United States
Jan Hommen
Doral, Florida, United States
Mira Baron
West Palm Beach, Florida, United States
Richard Radnovich
Boise, Idaho, United States
Thomas Schnitzer
Chicago, Illinois, United States
Nathan Rimmke
Rochester Hills, Michigan, United States
Larkin Wadsworth
St Louis, Missouri, United States
Duane C Anderson
Las Vegas, Nevada, United States
Igor Grosman
Brooklyn, New York, United States
Jonathan Samuels
New York, New York, United States
Minal Desai
Durham, North Carolina, United States
Jeremy Hoff
Wilmington, North Carolina, United States
Priyesh Mehta
Dayton, Ohio, United States
Edward Tavel
Charleston, South Carolina, United States
Sefanit Gebretsadik
Dallas, Texas, United States
Manjoo Sharma
Lewisville, Texas, United States
Haresh Boghara
Red Oak, Texas, United States
Leonel Reyes
San Antonio, Texas, United States
Lisa Blair
San Antonio, Texas, United States
David Scott
Spokane, Washington, United States