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Degenerative OsteoarthritisPhase 3NCT03203330

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

A Phase 3 study testing TG-C in people with Degenerative Osteoarthritis, run by Kolon TissueGene, Inc. at 44 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Degenerative Osteoarthritis
What is being tested?
TG-C
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
535 participants
Where
44 sitesUnited States
Study dates
30 Oct 2018to 18 Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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 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.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Diraj Karnani

    Apple Valley, California, 92307

  • James Nace

    Baltimore, Maryland, 21215

  • Daneshvari Solanki

    Bellaire, Texas, 77401

  • Jeffrey Davis

    Birmingham, Alabama, 35205

  • Bradly Goodman

    Birmingham, Alabama, 35235

  • Kristen Holtz

    Charlottesville, Virginia, 22901

  • Dennis Levinson

    Chicago, Illinois, 60607

  • Manish Jain

    Chicago, Illinois, 60640

  • Edward Tavel

    Columbia, South Carolina, 29206

  • Dan La

    Covina, California, 91722

  • Amr Morsy

    Dallas, Texas, 75240

  • Mark Hermann

    Danville, Virginia, 24541

  • David Billmeier

    Daytona Beach, Florida, 32117

  • Haresh Boghara

    DeSoto, Texas, 75115

  • Alan Kivitz

    Duncansville, Pennsylvania, 16635

  • Brett Gilbert

    Durham, North Carolina, 27704

  • Aldo Maspons

    El Paso, Texas, 79225

  • Eric Loudermilk

    Greenville, South Carolina, 29601

  • Subodh Bhuchar

    Houston, Texas, 77099

  • Scott Hacker

    La Mesa, California, 91942

  • Melvin Churchill

    Lincoln, Nebraska, 68516

  • Adil Fatakia

    Marrero, Louisiana, 70072

  • Mercedes Ponce De Leon

    Miami, Florida, 33135

  • Aurelio Torres-Consuegra

    Miami, Florida, 33144

  • Edgar Gonzalez

    Miami, Florida, 33144

  • Eric Grigsby

    Napa, California, 94558

  • Harvey Bowles

    Nashville, Tennessee, 37203

  • Cathy Barnes

    New Port Richey, Florida, 34652

  • Jason Oh

    New York, New York, 10075

  • Sandeep Vaid

    Newnan, Georgia, 30265

  • Hythem Shadid

    Oak Brook, Illinois, 60523

  • Howard Chipman

    Oldsmar, Florida, 34677

  • Saima Chohan

    Phoenix, Arizona, 85032

  • Brian MacGillivray

    San Antonio, Texas, 78258

  • Arthur Mabaquiao

    San Diego, California, 92108

  • Timothy Davis

    Santa Monica, California, 90403

  • John Hemmersmeier

    South Ogden, Utah, 84405

  • Richard Linn

    Sunrise, Florida, 33351

  • Nebojsa Skrepnik

    Tucson, Arizona, 85712

  • Yogesh Mittal

    Tulsa, Oklahoma, 74104

  • Mehul Desai

    Washington D.C., District of Columbia, 20006

  • Tien-I Su

    Whittier, California, 90602

  • Jeremy Hoff

    Wilmington, North Carolina, 28412

  • Anand Patel

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
TG-C, Placebo Control
Keywords
knee
Medical subject headings
Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG-CBiological

    Also called TissueGene-C

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

  • Placebo ControlBiological

    Also called Normal Saline

    2 mL normal saline injection

Study groups in NCT03203330
Study groupRoleWhat they receive
Active Treatment (TG-C)Active comparatorTG-C at 3 x 10e7 cells per single 2 mL intraarticular injection
Receives: Biological: TG-C
Placebo Control (Normal Saline)Placebo comparatorNormal saline, single 2 mL intraarticular injection
Receives: Biological: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)

    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.

    Measured: 12 months

  2. Change in Knee Pain as Assessed by VAS

    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.

    Measured: 12 months

Secondary outcomes (4)

  1. MRI Assessment of Target Knee

    Evaluation of the features of OA, as determined by structural changes of the knee joint, assessed by MRI

    Measured: 12 months

  2. PCS of the SF-12 Questionnaire

    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

    Measured: 12 months

  3. WOMAC Total Score

    Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score

    Measured: 24 months

  4. Health Assessment Questionnaire Disability Index

    Evaluation of the HRQoL as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2017
  2. Study start30 Oct 2018
  3. Primary completion10 Jul 2024
  4. Study completion18 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03203330
Sponsor's protocol ID
TGC-12301
Status last verified
Aug 2026
First submitted
21 Jun 2017
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33229973

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TG-C in people with Degenerative Osteoarthritis, run by Kolon TissueGene, Inc. at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03203330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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