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
Who is this study for? Older adult patients with Degenerative Osteoarthritis
What treatments are being studied? TissueGene-C
Status: Active_not_recruiting
Location: See all (46) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• Aged 40 or older
• BMI between 18.5 and 40
• KL Grade 2 or 3 knee OA
• OARSI Grade 1 or 2 medial JSN
• Pain \>= 40 on VAS scale
• Written informed consent
• Using birth control
Locations
United States
Alabama
Bradly Goodman
Birmingham
Jeffrey Davis
Birmingham
Arizona
Saima Chohan
Phoenix
Nebojsa Skrepnik
Tucson
California
Diraj Karnani
Apple Valley
Dan La
Covina
Scott Hacker
La Mesa
Eric Grigsby
Napa
Arthur Mabaquiao
San Diego
Timothy Davis
Santa Monica
Tien-I Su
Whittier
Washington, D.c.
Mehul Desai
Washington D.c.
Florida
David Billmeier
Daytona Beach
Aurelio Torres-Consuegra
Miami
Edgar Gonzalez
Miami
Mercedes Ponce De Leon
Miami
Cathy Barnes
New Port Richey
Howard Chipman
Oldsmar
Richard Linn
Sunrise
Anand Patel
Winter Park
Georgia
Sandeep Vaid
Newnan
Illinois
Dennis Levinson
Chicago
Manish Jain
Chicago
Hythem Shadid
Oak Brook
Louisiana
Adil Fatakia
Marrero
Maryland
Ronald Delanois
Baltimore
North Carolina
Brett Gilbert
Durham
Jeremy Hoff
Wilmington
Nebraska
Melvin Churchill
Lincoln
New York
Corey Hunter
New York
Jason Oh
New York
Oklahoma
Yogesh Mittal
Tulsa
Pennsylvania
Alan Kivitz
Duncansville
South Carolina
Edward Tavel
Columbia
Eric Loudermilk
Greenville
Tennessee
Harvey Bowles
Nashville
Texas
Daneshvari Solanki
Bellaire
Amr Morsy
Dallas
Haresh Boghara
Desoto
Aldo Maspons
El Paso
Subodh Bhuchar
Houston
Brian MacGillivray
San Antonio
Utah
Angela Krull
Draper
John Hemmersmeier
South Ogden
Virginia
James Clark
Charlottesville
Mark Hermann
Danville
Time Frame
Start Date: 2018-10-30
Completion Date: 2026-07-10
Participants
Target number of participants: 535
Treatments
Active_comparator: Active Treatment (TG-C)
TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
Placebo_comparator: Placebo Control (Normal Saline)
Normal saline, single 2 mL intraarticular injection
Authors
Related Therapeutic Areas
Sponsors
Leads: Kolon TissueGene, Inc.