Degenerative OsteoarthritisPhase 3NCT03291470
Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/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 27 sites in United States.
Trial 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… 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
- 531 participants
- Where
- 27 sitesUnited States
- Study dates
- 9 Dec 2021to 1 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Steve Sitar
Anaheim, California, 92801
Stuart Silverman
Beverly Hills, California, 90211
Richard Radnovich
Boise, Idaho, 83713
Igor Grosman
Brooklyn, New York, 11235
Edward Tavel
Charleston, South Carolina, 29406
Thomas Schnitzer
Chicago, Illinois, 60611
Miguel Trevino
Clearwater, Florida, 33756
Samy Metyas
Covina, California, 91722
Durga Tanneru
Dallas, Texas, 75230
Priyesh Mehta
Dayton, Ohio, 45432
Jan Hommen
Doral, Florida, 33126
Minal Desai
Durham, North Carolina, 27704
Bassil Aish
Huntington Beach, California, 92647
Peter Hanson
La Mesa, California, 91942
Robby Ann Quintos
Las Vegas, Nevada, 89109
Manjoo Sharma
Lewisville, Texas, 75057
Jonathan Samuels
New York, New York, 10016
Haresh Boghara
Red Oak, Texas, 75154
Nathan Rimmke
Rochester Hills, Michigan, 48307
Leonel Reyes
San Antonio, Texas, 78215
Lisa Blair
San Antonio, Texas, 78229
Duane Anderson
San Diego, California, 92120
David Scott
Spokane, Washington, 99218
Larkin Wadsworth
St Louis, Missouri, 63141
Nebojsa Skrepnik
Tucson, Arizona, 85712
Mira Baron
West Palm Beach, Florida, 33409
Jeremy Hoff
Wilmington, North Carolina, 28412
About this study
Official title: 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
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.
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 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
- Degenerative Osteoarthritis
- 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 intraarticular injection
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment (TG-C) | Active comparator | TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection Receives: Biological: TG-C |
| Placebo Control (Normal Saline) | Placebo comparator | Normal 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.
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
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)
MRI Assessment of Target Knee
Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS
Measured: 12 months
PCS of the SF-12 Questionnaire
Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.
Measured: 12 months
WOMAC Total Score
Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score
Measured: 24 Months
Health Assessment Questionnaire Disability Index
Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (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.
- First posted25 Sep 2017
- Study start9 Dec 2021
- Primary completion6 Mar 2024
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kolon TissueGene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moon Jong Noh, PhD, Study chair, Kolon TissueGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291470
- Sponsor's protocol ID
- TGC-15302
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03291470
- Acronym / sponsor ID
- TGC-15302
- Conditions
- Degenerative Osteoarthritis
- Keywords
- knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Kolon TissueGene, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment (TG-C) | Active comparator | Biological: TG-CTG-C at 3 x 10e7 cells per single 2 mL intraarticular injection |
| Placebo Control (Normal Saline) | Placebo comparator | Biological: Placebo ControlNormal saline, single 2 mL intraarticular injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG-CAlso: TissueGene-C2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1 | Biological | Active Treatment (TG-C) |
| Placebo ControlAlso: Normal Saline2 mL normal saline intraarticular injection | Biological | Placebo Control (Normal Saline) |
Primary outcome
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.
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.
4 secondary outcomes
MRI Assessment of Target Knee
Time frame: 12 months
PCS of the SF-12 Questionnaire
Time frame: 12 months
WOMAC Total Score
Time frame: 24 Months
Health Assessment Questionnaire Disability Index
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moon Jong Noh, PhD study chair
Kolon TissueGene
27 sites in 1 country: see every site and its status.
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 27 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: finished, 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 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.