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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

NCT ID: NCT03203330

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

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2026-07-10

Brief Summary

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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.

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 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.

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 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 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
* 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 rheumatoid arthritis, 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, or non-specified uncontrolled endocrine disorder
* Uncontrolled diabetes based on a HbA1c \> 8% at screening
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, Inc.

Locations

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Jeffrey Davis

Birmingham, Alabama, United States

Site Status

Bradly Goodman

Birmingham, Alabama, United States

Site Status

Saima Chohan

Phoenix, Arizona, United States

Site Status

Nebojsa Skrepnik

Tucson, Arizona, United States

Site Status

Diraj Karnani

Apple Valley, California, United States

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Dan La

Covina, California, United States

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Scott Hacker

La Mesa, California, United States

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Eric Grigsby

Napa, California, United States

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Arthur Mabaquiao

San Diego, California, United States

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Timothy Davis

Santa Monica, California, United States

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Tien-I Su

Whittier, California, United States

Site Status

Mehul Desai

Washington D.C., District of Columbia, United States

Site Status

David Billmeier

Daytona Beach, Florida, United States

Site Status

Mercedes Ponce De Leon

Miami, Florida, United States

Site Status

Aurelio Torres-Consuegra

Miami, Florida, United States

Site Status

Edgar Gonzalez

Miami, Florida, United States

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Cathy Barnes

New Port Richey, Florida, United States

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Howard Chipman

Oldsmar, Florida, United States

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Richard Linn

Sunrise, Florida, United States

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Anand Patel

Winter Park, Florida, United States

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Sandeep Vaid

Newnan, Georgia, United States

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Dennis Levinson

Chicago, Illinois, United States

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Manish Jain

Chicago, Illinois, United States

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Hythem Shadid

Oak Brook, Illinois, United States

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Adil Fatakia

Marrero, Louisiana, United States

Site Status

James Nace

Baltimore, Maryland, United States

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Melvin Churchill

Lincoln, Nebraska, United States

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Jason Oh

New York, New York, United States

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Brett Gilbert

Durham, North Carolina, United States

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Jeremy Hoff

Wilmington, North Carolina, United States

Site Status

Yogesh Mittal

Tulsa, Oklahoma, United States

Site Status

Alan Kivitz

Duncansville, Pennsylvania, United States

Site Status

Edward Tavel

Columbia, South Carolina, United States

Site Status

Eric Loudermilk

Greenville, South Carolina, United States

Site Status

Harvey Bowles

Nashville, Tennessee, United States

Site Status

Daneshvari Solanki

Bellaire, Texas, United States

Site Status

Amr Morsy

Dallas, Texas, United States

Site Status

Haresh Boghara

DeSoto, Texas, United States

Site Status

Aldo Maspons

El Paso, Texas, United States

Site Status

Subodh Bhuchar

Houston, Texas, United States

Site Status

Brian MacGillivray

San Antonio, Texas, United States

Site Status

John Hemmersmeier

South Ogden, Utah, United States

Site Status

Kristen Holtz

Charlottesville, Virginia, United States

Site Status

Mark Hermann

Danville, Virginia, United States

Site Status

Countries

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United States

References

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Mehta S, He T, Bajpayee AG. Recent advances in targeted drug delivery for treatment of osteoarthritis. Curr Opin Rheumatol. 2021 Jan;33(1):94-109. doi: 10.1097/BOR.0000000000000761.

Reference Type DERIVED
PMID: 33229973 (View on PubMed)

Other Identifiers

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TGC-12301

Identifier Type: -

Identifier Source: org_study_id