Could a single injection fix early hip arthritis?
NCT ID NCT05276011
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tests an experimental injection called TG-C for people with early hip osteoarthritis. The injection contains cells that release a growth factor to help repair damaged cartilage. 255 adults will receive either TG-C or a placebo, and researchers will track pain and hip function for 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TG-C (TissueGene-C) – a single injection of cells that release a growth factor to help repair cartilage
- What this could lead to
- If it works, this could lead to a non-surgical treatment that reduces hip pain and delays or prevents the need for hip replacement.
- What could go wrong
- This is an early Phase 2 trial with only 255 people, so results may not apply to everyone. The injection is new and long-term safety is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 255 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2027
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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; 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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