Study to Determine the Efficacy and Safety of TG-C in Subjects with Kellgren/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

TG-C

Placebo Control

Clinical Study ID

NCT03291470
TGC-15302
  • Ages > 40
  • All Genders

Study 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.

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

  • 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 or biologic therapy medication within 2 monthsof 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 disorder, chondrocalcinosis, gout,hemochromatosis, villonodular synovitis, or synovial chondromatosis

  • Severe hip osteoarthritis ipsilateral to the target knee

  • Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, orHCV.

  • 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.

  • Documented active malignancy within the last 5 years except for basal cellcarcinoma, squamous cell carcinoma, and benign pigmented nevi.

Study Design

Total Participants: 531
Treatment Group(s): 2
Primary Treatment: TG-C
Phase: 3
Study Start date:
December 09, 2021
Estimated Completion Date:
March 06, 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 K&L 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 dose for subjects who do not enroll in the Long Term Safety study.

Connect with a study center

  • Hayes Williams

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Ankit Patel

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • John Tesser

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Nebojsa Skrepnik

    Tucson, Arizona 85712
    United States

    Site Not Available

  • George Konis

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Steve Sitar

    Anaheim, California 92801
    United States

    Site Not Available

  • Stuart Silverman

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Samy Metyas

    Covina, California 91722
    United States

    Site Not Available

  • Bassil Aish

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Peter Hanson

    La Mesa, California 91942
    United States

    Site Not Available

  • Natalia Chavez Stewart

    Riverside, California 92518
    United States

    Site Not Available

  • John Beckes

    San Diego, California 92120
    United States

    Site Not Available

  • Hans Richard Barthel

    Santa Barbara, California 93108
    United States

    Site Not Available

  • Miguel Trevino

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Mark Hollmann

    DeLand, Florida 32720
    United States

    Site Not Available

  • Jan Hommen

    Doral, Florida 33126
    United States

    Site Not Available

  • Investigative Site

    Miami, Florida 33184
    United States

    Site Not Available

  • Mira Baron

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Ben Thomas

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Richard Radnovich

    Boise, Idaho 83713
    United States

    Site Not Available

  • Joel Block

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Thomas Schnitzer

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Nathan Rimmke

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Larkin Wadsworth

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Duane C Anderson

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Igor Grosman

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Jonathan Samuels

    New York, New York 10016
    United States

    Site Not Available

  • John Solic

    Durham, North Carolina 27704
    United States

    Site Not Available

  • Rakesh Patel

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Jeremy Hoff

    Wilmington, North Carolina 28412
    United States

    Site Not Available

  • Richard Rauck

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Priyesh Mehta

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Douglas Beall

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Edward Tavel

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • David Taunton

    Bedford, Texas 76021
    United States

    Site Not Available

  • Howsen Kwan

    Carrollton, Texas 75006
    United States

    Site Not Available

  • James Lilly

    Dallas, Texas 75230
    United States

    Site Not Available

  • Investigative Site

    Houston, Texas 77054
    United States

    Site Not Available

  • Manjoo Sharma

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Haresh Boghara

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Charles Andrews

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Leonel Reyes

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Maninder Guram

    Tomball, Texas 77375
    United States

    Site Not Available

  • Todd Bertoch

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • David Scott

    Spokane, Washington 99218
    United States

    Site Not Available

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