AzTrials
AzTrials

Degenerative OsteoarthritisPhase 2NCT05276011

A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis

A Phase 2 study testing TG-C in people with Degenerative Osteoarthritis, run by Kolon TissueGene, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture… Read more about this study

Who is it for?
Ages 18 to 80 years
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
255 participants
Where
No sites listed yet
Study dates
Oct 2027to Oct 2028
Phase
Phase 2
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 80 years old
  • The subject has a diagnosis of Grade ≤2 primary OA of the target hip
  • Pain ≥ 40 on VAS scale
  • The subject has groin pain that is elicited by hip rotation on physical examination
  • No history of significant organ system disorders.
  • Body mass index (BMI) <40 kg/m2
Show all 9Show fewer
  • Systolic blood pressure of 100 to 160 mmHg and diastolic blood pressure of 60 to 90 mmHg.
  • Using birth control
  • Written informed consent

Who cannot join

  • The subject exhibits severe symptoms in the target hip that result in difficulty or an inability to walk.
  • The subject has severe hip OA ipsilateral to the target hip.
  • Previous cartilage transplantation procedure to the injured cartilage surface.
  • Major injury to the target hip within 12 months of screening.
  • Active dermal ulcer or infection in the proximity of the target hip within 1 month before screening.
  • The subject has had surgery on the target hip within the last 6 months.
Show all 24Show fewer
  • Total hip replacement surgery or other surgery on the target hip in the next 12 months.
  • MRI indicates bone marrow infiltration, fracture, osteonecrosis/bone infarct, osteochondritis dissecans, tumor, moderate to severe dysplasia, avascular necrosis, post-traumatic arthritis, transient osteoporosis, slipped-cap femoral epiphysis, juvenile idiopathic arthritis, or axial juvenile spondyloarthritis.
  • Hip conditions including but not limited to any autoimmune or infectious cause for arthritis; metabolic joint disease; neuropathic disorders, groin pain from non-orthopedic sources, or tumors, congestive heart failure, or chronic kidney disease.
  • Uncontrolled diabetes based on a hemoglobin A1c (HbA1c) value >8% at the screening Visit.
  • Increased risk for post-procedure bleeding or post-procedure infection.
  • Ongoing infectious disease, including, but not limited to, HIV, hepatitis C, or current or prior hepatitis B.
  • Cognitive impairment that would limit his/her ability to provide informed consent or to complete assessments and questionnaires.
  • 1 year history of drug or alcohol abuse.
  • Contraindication to or cannot undergo MRI.
  • Active malignancy within the last 5 years.
  • Pregnant or is lactating.
  • Taken steroidal or NSAIDs within 14 days before the Baseline Visit
  • Using topical analgesics on the target hip
  • Receiving chronic narcotic treatment at screening.
  • Received any injection to the target hip within the 3 months before the Baseline Visit.
  • Taking antiplatelet or anticoagulants.
  • Participated in an investigational study within 13 weeks before the Screening Visit or in the next 25 months.
  • Unable to comply with the requisite study follow-up and all of the follow-up office visits.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

KTG Clinical contact

(301) 921-6000

KTGclinical@tissuegene.com

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects With Symptomatic Early Hip Osteoarthritis

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 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 hip and determining disease modifying effects of TG-C. TG-C will be compared to normal saline as a control. 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 12 months for both safety and efficacy.

Being tested
TG-C, Placebo Control
Keywords
hip
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 NCT05276011
Study groupRoleWhat they receive
Active Treatment (TG-C)Active comparatorTG-C at 1.0 x 10e7 cells per single 2 mL intraarticular injection
Receives: Biological: TG-C
Active Treatment 2 (TG-C)Active comparatorTG-C at 3.0 x 10e6 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 Hip Pain as Assessed by VAS

    Assessment of change from baseline in target hip 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: Baseline to Month 12

Secondary outcomes (5)

  1. Hip Disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS questionnaire was built upon the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC®). Questions from the WOMAC® were used as the basis for the survey, and 2 dimensions were added: sport and recreation and hip-related quality of life. The HOOS is composed of 40 questions in 5 subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items), and Hip-Related Quality of Life (4 items). A total score, ranging from 0 to 100 is calculated. Higher scores represent better functioning.

    Measured: Baseline to Month 12

  2. Timed Up and Go Test (TUG)

    The TUG test is used to determine the time needed to progress from sitting to standing and walking. In addition, the test helps to evaluate the probability for falls. The individual starts in a seated position in a chair with armrests and, upon command, stands up, walks 3 meters, turns around, walks back to the chair, and sits down. The time stops when the subject is seated. The use of walking aids should be recorded and kept consistent between tests.

    Measured: Baseline to Months 1, 3, 6, 9, and 12

  3. UCLA Activity Score

    The UCLA Activity Score includes 10 statements that cover the range of activity states from being "wholly inactive, dependent on others, and cannot leave residence" to "regularly participate in impact sports." The respondents are instructed to select one statement that is most representative of their current activity. Lower scores on the scale reflect a low level of activity and higher scores reflect more activity.

    Measured: Baseline to Months 1, 3, 6, 9, and 12

  4. Joint Space Width (JSW) on standing X-ray

    To evaluate the effects of 2 dose levels of TG-C on the structural features of the hip joint

    Measured: Baseline to Month 12

  5. WOMAC® (Western Ontario and McMaster Universities Osteoarthritis Index) total score

    To evaluate the effects of 2 dose levels of TG-C on symptoms of OA of the hip. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    Measured: Baseline to Month 12

Timeline

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

  1. First posted11 Mar 2022
  2. Study startOct 2027 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2028 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05276011
Sponsor's protocol ID
TGC-OAH-201
Status last verified
Aug 2026
First submitted
2 Mar 2022
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TG-C in people with Degenerative Osteoarthritis, run by Kolon TissueGene, Inc..

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 9 inclusion and 24 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: opening soon, 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.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact KTG Clinical ((301) 921-6000, KTGclinical@tissuegene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hip Pain as Assessed by VAS (time frame: Baseline to Month 12). 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 NCT05276011.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in