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ACTIVE NOT RECRUITING
NCT03291470
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

TG-C

2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1

BIOLOGICAL

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