Status:
NOT_YET_RECRUITING
A Study to Determine the Safety and Efficacy of TG-C in Subjects with Symptomatic Early Hip Osteoarthritis
Lead Sponsor:
Kolon TissueGene, Inc.
Conditions:
Degenerative Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 administer...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT05276011
Start Date
October 1 2025
End Date
October 1 2026
Last Update
December 11 2024
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