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Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee

NCT ID: NCT03291470

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2026-03-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Degenerative Osteoarthritis

Keywords

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knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind

Study Groups

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Active Treatment (TG-C)

TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection

Group Type ACTIVE_COMPARATOR

TG-C

Intervention Type BIOLOGICAL

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

Placebo Control (Normal Saline)

Normal saline, single 2 mL intraarticular injection

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type BIOLOGICAL

2 mL normal saline intraarticular injection

Interventions

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TG-C

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

Intervention Type BIOLOGICAL

Placebo Control

2 mL normal saline intraarticular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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TissueGene-C Normal Saline

Eligibility Criteria

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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 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 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 rheumatoid arthritis, 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, or HCV.
* Clinically significant congestive heart failure, hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder.
* Uncontrolled diabetes based on a HbA1c \> 8% at screening.
* Documented active malignancy within the last 5 years except for basal cell carcinoma, squamous cell carcinoma, and benign pigmented nevi.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kolon TissueGene, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moon Jong Noh, PhD

Role: STUDY_CHAIR

Kolon TissueGene

Locations

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Nebojsa Skrepnik

Tucson, Arizona, United States

Site Status

Steve Sitar

Anaheim, California, United States

Site Status

Stuart Silverman

Beverly Hills, California, United States

Site Status

Samy Metyas

Covina, California, United States

Site Status

Bassil Aish

Huntington Beach, California, United States

Site Status

Peter Hanson

La Mesa, California, United States

Site Status

John Beckes

San Diego, California, United States

Site Status

Miguel Trevino

Clearwater, Florida, United States

Site Status

Jan Hommen

Doral, Florida, United States

Site Status

Mira Baron

West Palm Beach, Florida, United States

Site Status

Richard Radnovich

Boise, Idaho, United States

Site Status

Thomas Schnitzer

Chicago, Illinois, United States

Site Status

Nathan Rimmke

Rochester Hills, Michigan, United States

Site Status

Larkin Wadsworth

St Louis, Missouri, United States

Site Status

Duane C Anderson

Las Vegas, Nevada, United States

Site Status

Igor Grosman

Brooklyn, New York, United States

Site Status

Jonathan Samuels

New York, New York, United States

Site Status

Minal Desai

Durham, North Carolina, United States

Site Status

Jeremy Hoff

Wilmington, North Carolina, United States

Site Status

Priyesh Mehta

Dayton, Ohio, United States

Site Status

Edward Tavel

Charleston, South Carolina, United States

Site Status

Sefanit Gebretsadik

Dallas, Texas, United States

Site Status

Manjoo Sharma

Lewisville, Texas, United States

Site Status

Haresh Boghara

Red Oak, Texas, United States

Site Status

Leonel Reyes

San Antonio, Texas, United States

Site Status

Lisa Blair

San Antonio, Texas, United States

Site Status

David Scott

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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TGC-15302

Identifier Type: -

Identifier Source: org_study_id