A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteo… (NCT05276011) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis
255 participantsStarted 2026-10
Plain-language 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 showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 months for safety and efficacy.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Systolic blood pressure of 100 to 160 mmHg and diastolic blood pressure of 60 to 90 mmHg.
* Using birth control
* Written informed consent
Exclusion Criteria:
* 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.
* 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; neur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial for TG-C in hip osteoarthritis, what do we currently know about the safety profile of TG-C, and what risks might I be taking on by participating at this early stage of testing?
2The trial isn't recruiting yet — how long do you think it might be before it opens, and is it worth waiting for it or should we focus on standard treatments in the meantime?
3The study is focused on 'early' hip osteoarthritis — based on how far along my condition is, do you think I would even be a candidate for this kind of trial when it does open?
4Since the main thing being measured is change in hip pain using a pain scale, does that mean we won't have strong data yet on whether TG-C actually slows the progression of my joint damage?
5What standard treatment options are available to me right now that we should consider before or instead of waiting for this experimental study to begin recruiting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.