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NCT05276011
A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis
Conditions: Degenerative Osteoarthritis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 255
Sponsor: Kolon TissueGene, Inc.
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.
Eligibility Criteria
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) \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.
Source: ClinicalTrials.gov (NCT05276011). StuddyBuddy aggregates publicly available trial information.