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

Last updated: December 6, 2024
Sponsor: Kolon TissueGene, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Osteoarthritis

Treatment

Placebo Control

TG-C

Clinical Study ID

NCT03203330
TGC-12301
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • Knee symptoms that result in difficulty or inability to walk

  • Knee effusion >2+

  • Has Grade 3 OARSI JSN

  • Has a score of 0 or >=5 on the cartilage feature of the WORMS at Screening

  • MRI exam indicates fracture or tumor

  • Has a positive result on RCR testing at Screening

  • Has taken NSAIDS with 14 days of baseline

  • Has taken steroidal anti-inflammatory medication within 2 months of baseline

  • Chronic (>21 days) narcotic use

  • Recent history (within 1 year) of drug or alcohol abuse

  • Pregnant or lactating

  • Has received injection to target knee within 2 months prior to study entry

  • History of various disorders of the knee including but not limited to rheumatoidarthritis, psoriatic arthritis, autoimmune OA, chondrocalcinosis, gout,hemochromatosis, villonodular synovitis, or synovial chondromatosis

  • Severe hip osteoarthritis ipsilateral to the target knee

  • Ongoing infection disease including but not limited to HIV, Hepatitis B or C.

  • Clinically significant congestive heart failure hepatic disease, kidney disease,adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, ornon-specified uncontrolled endocrine disorder

  • Uncontrolled diabetes based on a HbA1c > 8% at screening

Study Design

Total Participants: 535
Treatment Group(s): 2
Primary Treatment: Placebo Control
Phase: 3
Study Start date:
October 30, 2018
Estimated Completion Date:
July 10, 2026

Study Description

This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of osteoarthritis of the knee and determining disease modifying effects of TG-C. This study is intended for the treatment of patients with KL Grade 2 and 3 osteoarthritis and OARSI JSN Grade 1 and 2. Assessments will be made on both the symptomatic effects of pain (VAS), function (WOMAC), and Quality of Life (SF-12) as well as the physical effects (JSW, MRI evaluations of whole knee joint organ tissues and structure) and biochemical biomarkers. This is a placebo-controlled study, TG-C will be compared to normal saline as a control. Additionally, this protocol is designed to evaluate the safety of TG-C. Safety will be evaluated by observation of the injection site for irritation or other effects, the incidence and severity of adverse events, and changes in physical examination findings, radiographic criteria, and laboratory tests. Patients will be followed for 24 months for both safety and efficacy with annual cancer surveillance questionnaires through 15 years post dosing for subjects who do not enroll in the Long Term Safety study.

Connect with a study center

  • Bradly Goodman

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • Jeffrey Davis

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Saima Chohan

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Nebojsa Skrepnik

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Diraj Karnani

    Apple Valley, California 92307
    United States

    Site Not Available

  • Dan La

    Covina, California 91722
    United States

    Site Not Available

  • Investigative Site

    El Cajon, California 92020
    United States

    Site Not Available

  • Scott Hacker

    La Mesa, California 91942
    United States

    Site Not Available

  • Eric Grigsby

    Napa, California 94558
    United States

    Site Not Available

  • Arthur Mabaquiao

    San Diego, California 92108
    United States

    Site Not Available

  • Louis Levy

    San Diego, California 92108
    United States

    Active - Recruiting

  • Timothy Davis

    Santa Monica, California 90403
    United States

    Site Not Available

  • Janki Trivedi

    Sun City, California 92586
    United States

    Site Not Available

  • Charles Weidmann

    Van Nuys, California 90602
    United States

    Site Not Available

  • Tien-I Su

    Whittier, California 90602
    United States

    Site Not Available

  • Mehul Desai

    District of columbia, District of Columbia 20006
    United States

    Site Not Available

  • Mehul Desai

    Washington, District of Columbia 20006
    United States

    Site Not Available

  • John Randazzo

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Miguel Telleria

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • David Billmeier

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Kevin Shrock

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Aurelio Torres-Consuegra

    Miami, Florida 33144
    United States

    Site Not Available

  • Edgar Gonzalez

    Miami, Florida 33144
    United States

    Site Not Available

  • Mercedes Ponce De Leon

    Miami, Florida 33135
    United States

    Site Not Available

  • Cathy Barnes

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Howard Chipman

    Oldsmar, Florida 34677
    United States

    Site Not Available

  • Richard Linn

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Anand Patel

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Anthony Grasso Jr

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Sandeep Vaid

    Newnan, Georgia 30265
    United States

    Site Not Available

  • Francisco Chevres

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Dennis Levinson

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Manish Jain

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Thomas Schnitzer

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Hythem Shadid

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Investigative Site

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Adil Fatakia

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Ronald Delanois

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • David DiBenedetto

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Investigative Site

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Melvin Churchill

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Robert Kaplan

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Elena Katzap

    Great Neck, New York 11021
    United States

    Site Not Available

  • Corey Hunter

    New York, New York 10022
    United States

    Site Not Available

  • Jason Oh

    New York, New York 10075
    United States

    Site Not Available

  • Brett Gilbert

    Durham, North Carolina 27704
    United States

    Site Not Available

  • John Solic

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Jeremy Hoff

    Wilmington, North Carolina 28412
    United States

    Site Not Available

  • Steven Folkerth

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Yogesh Mittal

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Chris McClellan

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Alan Kivitz

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Javad Parvizi

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Ellis

    State College, Pennsylvania 16801
    United States

    Site Not Available

  • Investigative Site

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Edward Tavel

    Columbia, South Carolina 29206
    United States

    Site Not Available

  • Eric Loudermilk

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Shailesh Patel

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Harvey Bowles

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Jason Haslam

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Daneshvari Solanki

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Amr Morsy

    Dallas, Texas 75240
    United States

    Site Not Available

  • Haresh Boghara

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Aldo Maspons

    El Paso, Texas 79225
    United States

    Site Not Available

  • Subodh Bhuchar

    Houston, Texas 77099
    United States

    Site Not Available

  • Brian MacGillivray

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Angela Krull

    Draper, Utah 84020
    United States

    Site Not Available

  • David Jack

    Draper, Utah 84020
    United States

    Site Not Available

  • John Hemmersmeier

    South Ogden, Utah 84405
    United States

    Site Not Available

  • James Clark

    Charlottesville, Virginia 22901
    United States

    Site Not Available

  • Mark Hermann

    Danville, Virginia 24541
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.