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A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and 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 safety and efficacy 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 of TG-C in Subjects With Kellgren and Lawrence Grade (KLG) 2 or 3 Osteoarthritis of the Knee
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
535
Start Date
2018-10-30
Completion Date
2026-07-10
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 injection
Locations (44)
Jeffrey Davis
Birmingham, Alabama, United States
Bradly Goodman
Birmingham, Alabama, United States
Saima Chohan
Phoenix, Arizona, United States
Nebojsa Skrepnik
Tucson, Arizona, United States
Diraj Karnani
Apple Valley, California, United States
Dan La
Covina, California, United States
Scott Hacker
La Mesa, California, United States
Eric Grigsby
Napa, California, United States
Arthur Mabaquiao
San Diego, California, United States
Timothy Davis
Santa Monica, California, United States
Tien-I Su
Whittier, California, United States
Mehul Desai
Washington D.C., District of Columbia, United States
David Billmeier
Daytona Beach, Florida, United States
Mercedes Ponce De Leon
Miami, Florida, United States
Aurelio Torres-Consuegra
Miami, Florida, United States
Edgar Gonzalez
Miami, Florida, United States
Cathy Barnes
New Port Richey, Florida, United States
Howard Chipman
Oldsmar, Florida, United States
Richard Linn
Sunrise, Florida, United States
Anand Patel
Winter Park, Florida, United States
Sandeep Vaid
Newnan, Georgia, United States
Dennis Levinson
Chicago, Illinois, United States
Manish Jain
Chicago, Illinois, United States
Hythem Shadid
Oak Brook, Illinois, United States
Adil Fatakia
Marrero, Louisiana, United States
James Nace
Baltimore, Maryland, United States
Melvin Churchill
Lincoln, Nebraska, United States
Jason Oh
New York, New York, United States
Brett Gilbert
Durham, North Carolina, United States
Jeremy Hoff
Wilmington, North Carolina, United States
Yogesh Mittal
Tulsa, Oklahoma, United States
Alan Kivitz
Duncansville, Pennsylvania, United States
Edward Tavel
Columbia, South Carolina, United States
Eric Loudermilk
Greenville, South Carolina, United States
Harvey Bowles
Nashville, Tennessee, United States
Daneshvari Solanki
Bellaire, Texas, United States
Amr Morsy
Dallas, Texas, United States
Haresh Boghara
DeSoto, Texas, United States
Aldo Maspons
El Paso, Texas, United States
Subodh Bhuchar
Houston, Texas, United States
Brian MacGillivray
San Antonio, Texas, United States
John Hemmersmeier
South Ogden, Utah, United States
Kristen Holtz
Charlottesville, Virginia, United States
Mark Hermann
Danville, Virginia, United States