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

December 26, 2025 updated by: Kolon TissueGene, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
535

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Jeffrey Davis
      • Birmingham, Alabama, United States, 35235
        • Bradly Goodman
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Saima Chohan
      • Tucson, Arizona, United States, 85712
        • Nebojsa Skrepnik
    • California
      • Apple Valley, California, United States, 92307
        • Diraj Karnani
      • Covina, California, United States, 91722
        • Dan La
      • La Mesa, California, United States, 91942
        • Scott Hacker
      • Napa, California, United States, 94558
        • Eric Grigsby
      • San Diego, California, United States, 92108
        • Arthur Mabaquiao
      • Santa Monica, California, United States, 90403
        • Timothy Davis
      • Whittier, California, United States, 90602
        • Tien-I Su
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20006
        • Mehul Desai
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • David Billmeier
      • Miami, Florida, United States, 33135
        • Mercedes Ponce De Leon
      • Miami, Florida, United States, 33144
        • Aurelio Torres-Consuegra
      • Miami, Florida, United States, 33144
        • Edgar Gonzalez
      • New Port Richey, Florida, United States, 34652
        • Cathy Barnes
      • Oldsmar, Florida, United States, 34677
        • Howard Chipman
      • Sunrise, Florida, United States, 33351
        • Richard Linn
      • Winter Park, Florida, United States, 32789
        • Anand Patel
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Sandeep Vaid
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Dennis Levinson
      • Chicago, Illinois, United States, 60640
        • Manish Jain
      • Oak Brook, Illinois, United States, 60523
        • Hythem Shadid
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Adil Fatakia
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • James Nace
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Melvin Churchill
    • New York
      • New York, New York, United States, 10075
        • Jason Oh
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Brett Gilbert
      • Wilmington, North Carolina, United States, 28412
        • Jeremy Hoff
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Yogesh Mittal
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Alan Kivitz
    • South Carolina
      • Columbia, South Carolina, United States, 29206
        • Edward Tavel
      • Greenville, South Carolina, United States, 29601
        • Eric Loudermilk
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Harvey Bowles
    • Texas
      • Bellaire, Texas, United States, 77401
        • Daneshvari Solanki
      • Dallas, Texas, United States, 75240
        • Amr Morsy
      • DeSoto, Texas, United States, 75115
        • Haresh Boghara
      • El Paso, Texas, United States, 79225
        • Aldo Maspons
      • Houston, Texas, United States, 77099
        • Subodh Bhuchar
      • San Antonio, Texas, United States, 78258
        • Brian MacGillivray
    • Utah
      • South Ogden, Utah, United States, 84405
        • John Hemmersmeier
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Kristen Holtz
      • Danville, Virginia, United States, 24541
        • Mark Hermann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active Treatment (TG-C)
TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
Biological: TG-C
2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.
Other Names:
  • TissueGene-C
Placebo Comparator: Placebo Control (Normal Saline)
Normal saline, single 2 mL intraarticular injection
Biological: Placebo Control
2 mL normal saline injection
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)
Time Frame: 12 months
Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.
12 months
Change in Knee Pain as Assessed by VAS
Time Frame: 12 months
Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MRI Assessment of Target Knee
Time Frame: 12 months
Evaluation of the features of OA, as determined by structural changes of the knee joint, assessed by MRI
12 months
PCS of the SF-12 Questionnaire
Time Frame: 12 months
Evaluation the Health-Related Quality of Life (HRQoL) as measured by the physical component score (PCS) of the 12-Item Short-Form Health Survey version 2 (SF-12v2®) questionnaire
12 months
WOMAC Total Score
Time Frame: 24 months
Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
24 months
Health Assessment Questionnaire Disability Index
Time Frame: 12 months
Evaluation of the HRQoL as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiography for Structural Change in Knee Joint
Time Frame: Through 24 months
Evaluate structural changes of the knee joint as determined by radiography (X-ray)
Through 24 months
Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score
Time Frame: At Months 3, 6, 9 and 18
Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
At Months 3, 6, 9 and 18
Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores
Time Frame: Through 24 months
Evaluate the efficacy of TG-C with regard to knee function via WOMAC® pain, function, and stiffness scores
Through 24 months
Efficacy of TG-C with Regard to Knee Function via VAS Pain Score
Time Frame: At Day 1, Week 1, and Months 1, 3, 6, 9, 18 and 24
Evaluation of the efficacy of TG-C with regard to knee function via VAS pain score at time points other than Month 12
At Day 1, Week 1, and Months 1, 3, 6, 9, 18 and 24
OMERACT-OARSI Responder Analysis
Time Frame: 12 and 24 months
Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kolon TissueGene, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Moon Jong Noh, PhD, Kolon TissueGene, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TGC-12301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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